Pfizer

Upon immediate injection, reports joint pain on inner left wrist and left thumb. Day 2- present, experiencing increased joint pain on left wrist and thumb as well as swelling at base of thumb and inability to move, pinch, grab, stretch left hand. Occasionally pain spread up left forearm to elbow.

I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spontaneous report received from a non-contactable nurse (who is also the patient). A 26-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0140), intramuscular in right arm, on 29Dec2020 17:30, at single dose, for COVID-19 immunization. Medical history included spontaneous pneumothorax x2 on the right with VATS surgery on an unspecified date and multiple food allergies. The patient is not pregnant. Concomitant medication included montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient experienced shortness of breath, chest pain, body aches, joint pain, headache, nausea and congestion, all on 30Dec2020 at 05:00. The patient did not receive treatment for the events. The patent did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The reporter assessed the case as non-serious. No follow-up attempts are possible. No further information is expected.

I had nausea all day, heart rate over 120, pelvic & back pain, chills, normal temp of 98.6. Throughout the day my heart rate was at 125 even at sitting . My blood sugars were completely normal.

About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, fever, severe muscle soreness, active loss of smell and taste. General malaise and weakness.

mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower legs evening of vaccine; Felt mild headache; foggy feeling this night; This is a spontaneous report from a contactable healthcare professional, reporting for a patient. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231), intramuscular in the right arm on 30Dec2020 at 09:45 (at the age of 26-years-old) as a single dose for Covid-19 vaccination. Medical history included Covid-19 prior to the vaccination on an unknown date. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On 30Dec2020 at 19:30, the patient experienced diffuse myalgias, more severe on both right and left arm and numbness in lower legs the evening of the vaccine; felt mild headache and foggy feeling that night as well. The second day on 31Dec2020, the patient experienced mild flu-like symptoms such as weakness, fatigue, and myalgias. Therapeutic measures were taken for the myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness which included Tylenol. The clinical outcome of the events myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness was recovered on an unknown date.

Muscle and joint aches, nausea, chills. Worked 6am-1pm (went home early). Slept for 3 hours, no improvements. Hydrated, ate small dinner, went to bed. Woke up 4:45am for work and symptoms were gone.

On 01/07/2021 I woke up at 0300am with chills, headache, body aches, joint pain, fever of 101.2 and swollen left axillary lymph nodes. I took Tylenol and Benadryl and it relieved the fever/headache/body aches/joint pain, however the lymph nodes in my left axillary remained swollen. I continue to take Tylenol for the fever/body aches/pains without relief for the swollen and painful axillary lymph nodes. Warm compresses do help to relieve the pain temporarily but they remain painfully swollen. On 01/08/21 I called my doctors office to ask if it was normal to experience such painfully swollen axillary lymph nodes to which they stated ?we don?t know, it is too soon for us to tell what?s normal and what isn?t normal right now.? They did not offer any suggestions to relieve the pain or swelling. The morning of 01/09/2021 , I called Employee Health at my hospital (my place of work and also where I received the vaccine) and they also stated they didn?t know if this was a normal reaction due to the newness of the vaccine. A couple hours later, employee health emailed me a link to the VAERS reporting website and asked me to file a report.

Around 2 am the following day the side effects I was experiencing were fatigue and body/muscle aches (severe aches in my lower back and hips). This lasted the entire day until I went to bed around 10 o'clock. I had to use a heating pad for my back to reduce the pain.

Myalgias, joint aches, nausea, severe rigors and chills starting about 12 hours after administration of vaccine

Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache

Extreme body aches, chills, joint pain, fatigue. 800mg ibuprofen taken which somewhat relieved symptoms, but not completely.

I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under my left armpit with fever and chills and felt fatigued. My symptoms lasted two days. I slept a lot during the day and day after the injection . I did not get care from a hospital or doctor.

Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the night I began experiencing muscle aches, chills, headache, and just an overall feeling of pain/flu like symptoms. This lasted for approximately 24 hours.

Woke up at 1000 with severe body aches, sore neck, sore throat, mild headache, and nausea. Running a mild fever of 99.3F (baseline usually around 96.5-97.0). I took some Tylenol to elevate symptoms.

Swollen and painful axillary lymph nodes in the arm of the vaccine administration. Worst day after vaccination progressively improving over 5 days.

Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.

Low grade temperature; myalgias; fatigue; neck pain; injection site tenderness; This is a spontaneous report from a contactable physician (patient herself). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (right arm), on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left arm), on 17Dec2020, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021 at 21:00, the patient experienced low-grade temperature, myalgias, fatigue, neck pain, and injection site tenderness. The patient did not receive treatment for the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - Body aches - Joint aches - Headache About 40 hours after time of vaccine: - Fainting spells x2 (shakiness, blurry vision, ringing in ears, loss of balance)

Starting the day after the vaccine she had fatigue, fever, and a swollen and painful axillary lymph node on her left underam.

I did okay with the first dose only experienced site pain and fatigue. This second dose has not been pleasant: I am experiencing injection site pain, headaches, body aches, chills, and back pain.

severely sore arm; injured a ligament in the shoulder; Unable to lift arm; pain in shoulder and muscle; pain in shoulder and muscle; This is a spontaneous report from a contactable other healthcare professional (hcp). A 26-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date not reported), intramuscular on 07Jan2021 08:45 at a single dose in the left arm for COVID-19 immunization. Medical history included allergic to tree nuts and patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medication included tetanus vaccine on 02Jan2021 at a single dose. The patient had no other medications in two weeks. On 10Jan2021, the patient experienced severely sore arm as well as feeling as though patient injured a ligament in the shoulder. The patient was unable to lift arm without pain in shoulder and muscle. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Treatments was not received in response to the events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events severely sore arm, injured a ligament in the shoulder, unable to lift arm, and pain in shoulder and muscle. Information on the lot/batch number has been requested.

12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described as a nerve and muscle ache/throb, or "growing pains"/RLS symptoms. Put on compression socks which helped, but still too uncomfortable to sleep. Was able to sleep after taking ibuprofen 800mg and drinking water. 6 hours after the ibuprofen was administered, pain returned in lower legs as well as neck/ears with body temperature swings (cold, teeth chattering to sweating uncontrollably in a few minutes). After 1 hour of trying to sleep but failing, put compression socks back on. Temperature rose to 100-100.2 F, chills causing whole body to shake under multiple blankets. Tingling/muscle pains extremely uncomfortable and unable to rest, took another ibuprofen 800mg and water and was able to sleep. Tingling and muscle pains have continued as soon as ibuprofen wears off and come back more intense each time, most notably in the lower legs and near ears/neck and elbow of arm administered in (similar to "tennis elbow," assumed to be provoked by inflammation, happened with first dose).

2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.

1/13 AT 2AM AWOKE WITH CHILLS, FEVERISH (t99) HEADACHE FROM TOP OF HEAD DOWN TO POSTERIOR NECK, SORE THROAT, FATIGUE, MYALGIA AND ARTHRALGIA Did not work on 1/14/21- by 1/14/21 afternoon improved

Diarrhea, nausea, body aches, stiff neck, low grade fever , fatigue . Happened 6 hours after injection ( this happened when I got my first one too)

I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased over the course of two days. At approximately 12:30AM on 1/16/2021, extreme nausea, vomiting, fever, chills, and muscle aches began. During the day on 1/16/2021 severe joint pain (specifically bilateral knees and hips, and spine) occurred, somewhat relieved by Tylenol. On 1/17/2021 at 1:15AM, intense nausea, vomiting, and fever occurred again. As of 9:15AM on 1/17/2021, body aches and joint pain are returning and nausea is persistent.

My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.

Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse. A 26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.

Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, soreness at injection site, and chills. Jan 13th- chills and fatigue. Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue, body aches and chills. Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue, body aches, chills, sore throat, left ear pain and nausea. Jan 20th- sore throat, body aches, fatigue, hives

Swollen lymph nodes on left collar bone area on neck; Neck muscle pain, left arm muscle pain near armpit; This is a spontaneous report from a non-contactable nurse(patient). A 26-year-old female patient received first dose BNT162B2( lot number EL1284) , via an unspecified route of administration at Arm Left on 29Dec2020 15:30 at the 26 years old at single dose for COVID-19 immunization. The medical history was none. There were not known allergies. The concomitant medication included fluoxetine hydrochloride(PROZAC). On 06Jan2021 the patient experienced Swollen lymph nodes on left collar bone area on neck, neck muscle pain, left arm muscle pain near armpit. There was no treatment received for the events. There was no other vaccine in four weeks. There was not covid prior vaccination. There was not covid tested post vaccination. The outcome of the events was not recovered. No follow up attempts are possible. No further information is expected.

Symptoms within first 6-24 hours of receiving 2nd dose: moderate pain at injection site, body/muscle aches, chills, intermittent headache and fatigue

At 1 AM on 1/19/21, I awoke with chills, a fever of 101, neck pain, muscle pain, joint pain, and a severe headache. This persisted throughout the night and I did not sleep. Took 1000 mg of Acetaminophen at 5:30 and slept until 7 AM. By 8 AM, my temperature was back down to 98 F. Took 500 mg of Acetaminophen at 10 AM with food. Headache, muscle pain, and joint pain persisted. Moderate to severe chest pain began 15 mins after eating at 4 PM. Waited 30 mins to see if it resolved; it did not. Went to the urgent care. Chest x-ray and EKG was performed, no issues found. Was diagnosed with costochondritis and was given a steroid shot and ibuprofen, which reduced the pain significantly within 30 mins later.

The first side effect appeared around 8:30 pm. I felt extremely cold and got chills. I put an additional sweater on but the chills increases. I developed a fever by 10 pm. My entire body started shivering by 11:30 pm and I was feeling extremely cold. Additionally, I had extreme body and joint pain. The joint pain were especially in me knees, elbows, and my back. I felt sick to my stomach but did not vomit. The next day (Jan 20) I still had extreme body and joint pain, a strong migraine, fever, and felt very fatigue.

First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated with numbness and weakness of the Left Arm, Left Leg, Left side of the face.

Pfizer-BioNTech COVID-19 Vaccine EUA: One day after vaccination, patient presented to the emergency department with substernal chest pain and shortness of breath. History significant for COVID-19 "a few months ago". Initialy patient felt fatigued with muscle aches and fevers that were "worse than COVID itself". No cough, nausea, vomiting, abdominal pain, or rash reported. Initial vital signs: pulse 81 beats per minute, blood pressure 117/82 mmHg, temperature 36.7 degrees celsius, respiratory rate 18 breaths per minute, and oxygen saturation 97%. Patient observed, administered potassium and ketorolac, and symptoms resolved. Vitals remained within normal ranges and patient discharged home ambulatory and stable.

Dizziness 2 hours after vaccination, lasted up to 3 hours later. Chills and nausea 3 hours after vaccination, lasted 1-2 hours. Joint pain in hip 1 and 2 days after vaccination. Chills, fever, muscle fatigue 2 days after vaccination.

Muscle aches, headache, chills, nausea, diarrhea, chills, right arm pain, severe right armpit swelling (lymph node swelling).

Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.

Sore throat; Headache; Fatigue; Muscle and Joint pain; Muscle and Joint pain; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302; expiry date: unknown) intramuscular, in the left arm, on 11Jan2021 at 09:15, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), and seasonal allergies. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS), calcium, fexofenadine hydrochloride (ALLEGRA), and esomeprazole magnesium (NEXIUM). The patient previously received ibuprofen and drospirenone and experienced allergies; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) intramuscular in the left arm, on 21Dec2020, for COVID-19 immunization. On 11Jan2021, at 22:30, the patient experienced headache, fatigue, muscle and joint pain, and sore throat. The patient received naproxen and Tylenol as treatment for the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced chills and myalgia through the night. I did not improve when I woke up on 01/25. The chills and myalgia worsened and were complicated by vomiting without blood. I called off sick from work and took 3 Aleve tablets. I went back to sleep with improvement in symptoms approximately 6 hours later, with only mild myalgias and a very sore L. arm. Symptoms completely resolved by the morning of 01/26.

syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation. Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility. No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Headache, muscle ache and fever 11 hours post vaccine. Treatment include Ibuprofen with resolution of fever and improvement of headache and muscle aches. Does not interfere with ADLs.

Pfizer-BioNTech COVID-19 Vaccine 17 hours post-vaccine: a brief moment of dizziness before waking and weakness upon waking but subsiding immediately. Upon waking: left sided neck pain, and left sided chest pain aggravated only by extending left arm forward. 24 hours post-vaccine: fatigue and brain foggyness 30 hours post-vaccine: aforementioned joint pain relieves 48 hours post-vaccine: relief of most symptoms

severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.

Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough for a fever. I took Bayer for the muscle pain and slept. Developed soreness of injection site approximately an hour after injection. Muscle stiffness and joint pain began that night. Other symptomst started Thursday morning and ended Friday morning.

in the injection site she has a "large mass hard and stiff"; large mass and it hasn't resolved. The area was really hard and stiff; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 07Jan2021 07:00 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She received the first dose of the vaccine on Thursday and in the injection site she has a "large mass hard and stiff", she's concerned about this and she would like to know what she can do. In the injection area a large mass and it hasn't resolved. The area was really hard and stiff. Wanted to know if she should be concerned or be seen. Received the first dose on 07Jan2021 and kind of had this issue with the injection arm all week and maybe noticed it Tuesday because she was afraid to sleep on that side. No history of problems with vaccines in past. She is due for the second dose on 28Jan2021. Caller later provides that she is breastfeeding at the moment, but no further details provided. The events did not result to a physician office and emergency room visit. Vaccination Facility Type was hospital. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done and no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event was reported as non-serious. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051752 mother/baby

Headache; chills; sweating; nausea; tonsil stones; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for herself). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (left arm) on 12Jan2021 (12:15 PM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) intramuscular (left arm) on 23Dec2020 (03:00 PM) for Covid-19 immunization. The patient's medical history included migraines and anemia; no known allergies. Concomitant medications included spironolactone, frovatriptan succinate, ethinylestradiol, norgestimate (TRI-SPRINTEC), and ferrous sulfate. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, chills, sweating, nausea, tonsil stones, and muscle aches on 13Jan2021 (07:00 AM). There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.

Severe, debilitating muscle and joint paints. Hardly able to walk due to pain. Associated with frontal headache. No pain relief with otc Tylenol not Motrin . Symptoms lasted for 24 hours

Muscle ache localized to the right arm, shoulder and neck. Significant tenderness in R deltoid (injection site).

Patient received 2nd dose of COVID vaccine (Pfizer) 24 hours before adverse reaction began. Patient was originally having fever, muscle aches, and fatigue. Patient began having sharp, non radiating pain to substernal area and began feeling short of breath which brought her to the hospital.

Arm pain, left leg pain, back pain, neck pain, shooting pain on side, chest pain when breathing, fever, headache

Fever; chills; headache; myalgia; fatigue; sore arm; This is a spontaneous report from a Non-contactable Consumer (Patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at Left arm on 17Jan2021 14:00 at single dose for covid-19 immunization. Patient was not pregnant. Medical history included COVID-19 prior vaccination. The COVID-19 vaccine was administered at Hospital. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's received the first dose of BNT162B2 on 26Dec2020 at left arm for covid-19 immunization. The patient experienced Fever, chills, headache, myalgia, fatigue, sore arm on 17Jan2021 23:00. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Jan2021. No treatment received for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Muscle aches, chills, and fatigue started at 4 pm on 1/13/2021. Low-grade fever set in around 6 pm on 1/13/2021. Symptoms lasted until the next morning of 1/14/2021.

sore arm; joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pai; body aches all over; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140, expiration date was not reported), intramuscular in left arm on 18Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included headaches of an unknown origin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant. She did no receive any other vaccine four weeks prior covid vaccine. She did not have covid prior to vaccination. She was not tested for covid post vaccination. She had no known allergies. The patient reported adverse events for the first shot: Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain; and body aches all over for the next 2 days. The events' onset was on 18Dec2020 at 07:00 PM. Outcome recovered for events 'Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain' was recovered in Dec2020, while body aches all over was recovered on 20Dec2020.No treatment received for the events.

Date of start of drug 18Dec2020/ Date of start of drug 12Jan2021; Date of start of drug 18Dec2020/ Date of start of drug 12Jan2021; Dizziness; nausea; fever; joint pain; body aches; throbbing headache x 24 hours; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received BNT162b2 BNT162b2 (lot number: EL3246) second dose on 12Jan2021 on Right Arm at single dose for covid-19 immunization. Medical history included Headaches of an unknown origin. Concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. Patient is not pregnant. The patient previously took BNT162b2 (lot number: EL0140) first dose on 18Dec2020 12:00 PM (age 26-year-old) Intramuscular on left arm at single dose for covid-19 immunization and experienced Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain and body aches all over for the next 2 days. For 2nd shot: Dizziness, nausea, fever, body aches, joint pain, throbbing headache x 24 hours. Started at 9pm on the evening of the shot (12Jan2021) and symptoms ceased exactly 24 hours later. The outcome of the events was recovered on 13Jan2021 21:00. No treatment for the events.

Got second dose COVID-19 vaccine 1/29/2021, and it looked like it was given very high and she immediately had pain and discomfort. 2 hours later she had excruciating pain in her shoulder and had difficulty moving the shoulder. She is taking ibuprofen and it better. She still has pain and has occasionally shooting pains. She can move it normally now however and began taking ibuprofen prn

Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that night into Sunday and Monday. Chills and muscle aches

Muscle aches, weakness, fever, chills, slightly swollen face and lymph nodes, injection site pain, feeling unwell, fatigue.

About 2 minutes after injection, I had a sudden rush of warmth throughout my body starting in my abdomen then causing my pulse to feel like it was pounding out of my neck. Got light headed. EMS came and my blood pressure raised to 155/95 and my pulse was up in the 150s and I was shaking. Started to go down but felt crappy for over 2 hours. Happened again 30seconds after the second injection. Pulse up to almost 160. 02 stats stayed normal. Post first injection had sore arm and lots of fatigue and brain fog. Following the second injection 12 hours post started having nausea, and diarrhea. Continued to have joint pain, muscle aches, headaches for days, and my lymph nodes swelled up and were extremely painful.

Extreme soreness. Tiredness for half an hour. Strep like symptoms 2 weeks later. Strep test done but negative. Pain in lympth nodes. No fever and mild soreness in muscles. Pressure on forehead and headache that lasted 3 days possible 4 days.

Went to ED on 1/14/21. emailed caregiver for information. As far as what happened, I received my 2nd dose of Pfizer on Jan. 13th @ 05:15 at hospital and started feeling symptoms roughly six hours later, symptoms being nausea, chills, splitting headaches, muscle fatigue, feeling tired and joint pain. I had understood that these side effects were common and not to worry, however, the next day on Jan. 14th around 11:00am, I blacked out at home. Luckily, my partner had caught me before I feel to the ground, but he stated that my eyes had glazed over, my breathing was shallow, and I hardly had a pulse. He was getting ready to do chest compressions, but I had come out of whatever fog that had knocked me down and became responsive. Around 12:00 pm I had arrived at the ED where they had given me a bag on NS, Zofran for the nausea and Toradol for some inflammation management. I believe I discharged from the ED around 15:20.

received covid vaccine Monday morning. became sick with body aches, joint pain, sweating early Tuesday morning. called out sick for Tuesday shift 11am-7pm.

chills; fatigue; muscle aches; fever of 101; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 1284 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 14:30 at a single dose for COVID-19 immunization. There were no medical history. Patient was not pregnant at the time of vaccination. There were no other medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks. The patient chills, fatigue, muscle aches and fever of 101 on 20Jan2021 11:00. No treatment was received. Outcome of the events was recovering.

tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fever/low grade temp of 99.4; Headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left deltoid on 20Jan2021 11:00 at 0.3 mL, single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received her first dose yesterday at 11:00am. She was talking to someone and all of a sudden she got throat to neck pain that was intense that lasted two minutes on 21Jan2021. It has been about 10-15minutes since and if she hold her neck straight she is fine, but if she looks up it hurts. She can breathe fine. It hurts to swallow all of a sudden on 21Jan2021. Asking if it is normal to experience this. She had a low grade fever/low grade temp of 99.4, body aches, and a headache that started today 21Jan2021. She received Tylenol as treatment. States she is a nurse and she is tired. Her head feels fuzzy, she has not taken her temperature recently and it still hurts to swallow. The events did not require a visit to emergency room or physician office. Relatedness of drug to events from reporter for throat and neck pain, hurts to swallow, low grade fever, headache, body aches was reported as related. Reporter seriousness for throat and neck pain and hurts to swallow was medically significant. Event outcome of throat and neck pain was recovered, of hurts to swallow was not recovered, of others was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The reported events were likely causally related to the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. However, it is worth noting that the reporter/user of the vaccine was nurse, and her tiredness from job could have confounded with the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Muscle pain; fatigue; This is a spontaneous report from a contactable consumer who is reporting for herself. A 26-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration left arm single dose on 21Jan2021 12:30 for covid-19 immunisation. No other vaccine was received in four weeks. The patient medical history was not reported. There were no concomitant medications. The patient experienced muscle pain on Jan2021, fatigue on Jan2021. No treatment received. The outcome was not recovered

Lymphadenopathy on right side of body, lymph node pain, fatigue, nausea, muscle pain, joint pain, fever

The vaccine was inadequately administered, too deep and too high, into the shoulder bursa. The patient developed sharp pain soon after which persisted for two days. Soon after she started with neurological symptoms including increased sweating in the affected arm, pain in the branchial plexus region, including arm and forearm, paresthesias in arm, forearm, and fingers, sensation of scapula being dislocated, and tightening sensation in the lateral aspect of the chest. Symptoms are worsening every day. There is a high suspicion that she is developing Parsonage-Turner syndrome.

26 y.o. female with a copper IUD who received second dose of Pfizer vaccine. Developed vomiting, myalgia, and fever next day. These symptoms resolved but then developed pink colored hematuria two days post vaccine, and was seen in clinic that day. Urine sample collected with 4-10 RBCs and moderate amount of blood found from lab. Last menses two weeks ago. She did have similar issues years ago, but past lab results were not available. Was referred to urology.

Sharp left arm pain from fingertips to neck. Most significant pain in medial arm above elbow with radiating pain to pinky and ring finger to the shoulder and neck. Pain lasted 5+ days (pain worsened until day 3 and began to diminish on day 4). Also experienced body aches and tiredness on day after vaccine was administered.

fever, chills, rigors, muscle weakness, joint pain, lasted for approximately 48 hours beginning approximately the morning following the dose (dose given ~5 pm)

Soreness at injection site as well as anterior shoulder pain. Soreness at injection site resolved., but continues to have anterior shoulder pain.

These symptoms started the evening of my vaccine and lasted for 4 days (1/28/2021 through 1/31/2021). Uncontrollable chills, severe body aches, upper/middle back pain, neck pain/stiffness, extreme fatigue, ear aches, raging frontal and occipital headache, and hives (white in color on both legs - inner knee area), itchy neck and chest. Benadryl taken for hives. Ibuprofen taken for other side effects. No treatment/OTC medication provided real relief until late evening of day 3 after vaccine. Hives and side effects resolved entirely after 4-5 days post-vaccine. White hives turned into red healing rash-like bumps and eventually disappeared entirely.

Chills- night of vaccine all the way through the next day 2/13 Muscle aches & exhaustion- 2/13/21 lasted all day for one day. Required extra sleep + acetaminophen & ibuprofen Hives- Woke up 2/14 will small itchy patches all over the body (shoulders, back, stomach, legs, hands, feet). Took benadryl for treatment. Still itching all day 2/15/21 Sharp chest pain 2/14. Pain started halfway through the day and throughout the night. OTC pain medication had no effect. Disappeared after sleeping and waking up on Monday 2/15 Swollen lymph node in the left armpit (vaccine arm)- slight pain/tenderness. Started 2/14 in the morning. Still slightly tender as of end of the day 2/15

13 hours post vaccine: muscle body aches all over. About 16 hour mark: feverish, chills. Lasting throughout the night. Took 2 ibuprofen 200 mg 25 hours after. Vomited once.

I received my COVID19 vaccines on 12/31/2020 and 1/21/2021. On 2/3/2021 I woke up with pain, swelling, redness, and decreased range of motion in my R elbow at the site where I had hardware (wires, pins, tension band) placed during a surgical repair of my olecranon process in 2013. I have never had any issues with this elbow since the surgery, and no illnesses/dental work/medication changes in the months before this. The only change was getting my COVID vaccine. I went to see my PCP Dr. who advised me to go to the ER due to fear of a potential infection based on these symptoms. I went to the ER and after extensive testing they ruled out this being an infectious cause, though I was put on PO doxycycline as a precaution. An orthopedic specialist came to see me and determined that my body is essentially rejecting the hardware and I need to have surgery to have it removed. Since then, the swelling has decreased, however I still have persistent pain in my elbow along the site where the hardware is inserted and limited mobility due to pain with certain movements that put tension on this joint. I will need to have surgery eventually to have the hardware removed but am hoping to wait a couple months so that I can complete nursing school. I was advised to report any potential side effects from this vaccine and am choosing to do so as I do not know of any other reason this could be happening.

Fast onset of fatigue, joint pain, headache, pain of lymph nodes. Quickly worsening over 5 hours, remaining for approximately 30 hours.

Pt states she developed muscle aches about 12 hours after receiving the vaccine and the muscle aches continued for 24 hours. She states the muscle aches has resolved now.

It started 5-6 hours after the shot with headache and dizziness . In the evening I had a fever of 37,6°C and because I was scared it will be higher I took pills for fever. On the second day I had muscular pain and my fingers were swollen in the morning. Also I had lower back pain, runny nose and I was nauseous . On the 3rd day I was feeling dizzy, nauseous, couldn't concentrate and an intense headache. Pills weren't helping at all

"Staff member received 2nd dose Covid vaccine at 1355, began experiencing what she described as "similar to first dose"" (unreported) tingling in left arm approx. 10 minutes after receiving vaccine in Left arm. This progressed to tingling in her left leg/foot and 'weakened' left arm and left chest tightness 25 minutes after receiving vaccine. She reported s/s to IOH Lead at that time and monitoring began, Benadryl 25mg given P.O. BP at 1435 135/84, HR 90, Pox 100%, At 1445 Staff members reported improved s/s in arm, but right foot tingling. BP 124/79, HR 90, Pox 100%. At 1455 No s/s left arm or leg, no further chest tightness. BP 123/83, HR 95, Pox 100%. 1500 After standing for 5 minutes, BP 126/90, HR 96, Po 99%. Staff member stated she was ready to return to work. She will call fiancé to pick her up from work."

That night my fever 102 took Tylenol to bring it down, shakes, chills , nausea, muscle aches and swollen lymph nodes (right armpit).The symptoms lasted to Sunday. My estimated date of delivery was Sept.14 I miscarried at 5 wks.

830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensation internally. Medications to stop allergic reaction given by IV. Discharged home. Slight fever currently, muscle and body aches and pains. Joint pain. Headache.

fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the armpit underneath the injection site; pain and tenderness at injection site as well as in the armpit underneath the injection site; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis (not yet clear if Hashimoto's or Graves), appendicectomy and pyelonephritis. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride (VALACYCLOVIR HCL), ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium. The patient did not receive other vaccine in four weeks. The patient previously took azithromycin but drug allergy. The patient received the first dose of of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 05Jan2021 02:15 PM at a single dose for covid-19 immunization but had pain and tenderness at the injection site. It was reported that the patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine in a hospital on 26Jan2021 12:15. On 27Jan2021 12:00 AM, the patient had fever, chills, headache, overall fatigue, pain and tenderness at injection site as well as in the armpit underneath the injection site. The events required treatment which included acetaminophen. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Slight pain at the injection site; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; Slight nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 26Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA), valacyclovir, cyanocobalamin (B12), iron, and colecalciferol (D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021, the patient experienced slight pain at the injection site, muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night, and slight nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

I got the shot on February 5th, 2021. On the day of my injection, I immediately felt a stiffness in my arm within 10 minutes of receiving the shot. I didn't think too much of it because I had some stiffness in my arm with the first shot. But this Friday - March 5th will be a month and I am still having arm issues and they have gotten worse. I never had a rash or bruise on the injection site but from the injection site I have a tenderness on my arm and a constant dull and achy pain - sometimes sharp and painful - that starts at the injection site then travels down through my elbow and into my hand. My hand will get tingly and numb as well. My arm will sometimes randomly fall asleep as well. I went to the doctor but they gave me ibuprofen and that didn't do much. I am going back to the doctor soon.

Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.

nausea; vomiting; chills; joint and muscle pain; joint and muscle pain; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 26-year-old, on an unspecified date, at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date, single dose for COVID-19 immunization. On an unspecified date, following administration of second COVID-19 vaccine, the patient experienced nausea and vomiting, chills, joint and muscle pain, headache, and fatigue. Onset of symptoms occurred approximately 5 hours after administration of medication and became progressively worse over the next 20-24 hours following administration of dose. Symptoms began to resolve around 26 hours post administration of medication. Outcome of the events was recovering at the time of the report. No follow-up attempts are possible. Information about batch number cannot be obtained.

Employee exhibited respiratory illness from 2/27 - runny nose, dry cough, afebrile, myalgia. No known exposures.

Patient reports back on the side of spine (right lumbar pressure). Patient reports a lot of pressure, and cannot move. Patient took Tylenol before vaccination at 10AM and was vaccinated at 11AM. Patient reports pain starting when she tried to bend down to get a dress. Then the patient experienced sharp pain thereafter where she cannot stand or move.

Received both doses of Pfizer covid vaccine (1st dose on 1/21/2021, 2nd dose on 2/11/21. Then presented to ER on 3/08 with fevers, severe HAs and Back pain. Clean CXR, normal u/a, negative covid test. Evaluated by ID who feels meningitis is most likely diagnosis. unclear if there would be a relationship to the COVID vaccine or not.

Extreme soreness in left arm - to the point raising arm to remove clothing was difficult, migraine, sharp lower back pain, full body chills, feverish, loss of appetite, dizziness, full body fatigue.

Pain and swelling at injection site, muscle of injected arm is achy, hard to lift even to shoulder-height, itching at injection site, body aches, headache, upset stomach/nausea (but no vomiting or diarrhea)

At around 10 hours after receiving the vaccine, i had noticeable side effects. The worst one was chills. I had sudden and severe chills for several hours. 2 hours later i developed a severe headache, mild nausea, and muscle aches. The next morning, i felt very tired and had moderate muscle aches all day long.

102F fever, headache and joint pains about 14 hours after the shot. Headache better on day 2 but fever continued until I took Tylenol. Started to feel nauseous starting Day 2.

Staff member called a Health Office 3-16-2021 10:40am and reported since COVID-19 vaccine #2 on 1-29-2021 IM to left deltoid, she's had constant dull, aching pain level 3/10 to her left upper arm deltoid area. States pain occasionally radiates to left axilla, but never below her elbow. Denies redness or swelling. States pain relieved with over the counter Tylenol as needed. Has appointment with her doctor 3-16-2021 for evaluation of pain.

-fever: hot then cold frequently, night sweats and chills -muscle soreness: neck and back - lymph nodes in left armpit/chest area (I received my shot in my left arm)

14 hours after vaccination: Fever, full body aches, headache, full body tremors, increased thirst Next day: low grade fever, sore muscles, headache, increased thirst

Within two hours of my shot, I had a headache/muscle aches and felt dizzy/dissociated, and left work early. I started to feel feverish in the early evening, I began experiencing nausea around 3 am that night. This became vomiting about twenty minutes later. I vomited four times over the course of the next half hour: 3:30-4:00 am. I also started experiencing diarrhea at about 4:00 am. I had five loose, near-water stools over the course of the rest of the night until around 9 am, two of which I vomited at the same time. By the time the worst of it stopped, I'd vomited 10 times from 3:30 am - 10 am. I also experienced a fever from that afternoon onward, with chills/night sweats throughout the worst of the digestive upset until the morning. I couldn't keep fluids down until midmorning 3/18 and couldn't keep solids down until that evening, around 7 pm. It's 3/19 and I've had two glasses of water and a piece of toast and still feel nauseous. A friend of mine had some Zofran, which I took one dose of around 10 am 3/18, which allowed me to keep fluids down and not have to return to the hospital.

103 degree fever, headache, fatigue, muscle and joint pain, injection site pain, chills, fever, and nausea. Developed symptoms starting at about noon the day after vaccination and progressively got worse throughout the afternoon and evening. Symptoms made it impossible to conduct normal activities but have mostly resolved in the second day.

nausea - from 0400 2/4 until 1600 2/4 vomiting x1 episode 2/4 at 0830 myalgias, fatigue, fever and chills from 0400 2/4 until 2/6 pounding headache all day 2/4 and 2/5

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain tiredness headache stuffiness muscle pain, pain at base of head and top of neck, hip pain, knee pain chills fever (2 days at 100F) nausea dizziness itchiness

I was 34 weeks at the time of vaccination. Initially, I only had pain at the injection site. I woke up the next day with diarrhea that lasted about 6 days. I had no other symptoms besides dehydration and back pain. On Day 3, I was instructed to take Imodium, which I took for about 2 days, but it didn't help. Around Day 5, I was given fluids, my urine was tested and multiple GI tests were run. I was placed on antibiotics for a UTI. PVCs were also discovered at visit, but it's not connected to the vaccine.

Patient complained of tingling to left arm at 10:05, no dizziness or lightheadedness, vital signs normal. Per patient, she has history of anxiety. Patient drank water and orange juice with improvement to tingling noted at 10:17. At 10:22, patient still complaining of pain/tightness/tingling in arm, so Tylenol 325 mg was given. Patient left at 10:34 stable and was advised to follow up with PCP if symptoms persist.

The day of vaccination I started feeling the left side of my body heavy (starting from my face to my leg). My column also hurted a lot and I had a severe headache. It?s been almost 3 weeks since vaccination and I?ve been to several doctors and the emergency room and right now they have me taking B12, Neurontin and Cortisone. During my second week after the vaccine both my legs started feeling heavy to the point where there are days where I can?t feel them or they feel extremely heavy to move, my column still hurts till this date. Tomorrow I have another doctors appointment in order to continue investigating what I have. I?m still waiting for an official diagnosis which is why I can?t give an official answer for item 21 (I still don?t know if the damages will be permanent). Due to this situation I haven?t been able to go to work.

Notice significant enlargement of lymph node in right clavicular region near clavicle bone/neck. Tender to palpation and when turning head side to side. Also had pain in right armpit but never located enlargement.

Fever, chills, body aches, muscle and joint pain, nausea, vomiting, diarrhea, trouble concentrating , headache. These symptoms lasted about 30 hours. Headache, trouble concentrating, pain at injection site have lasted almost 48 hours and continue to exist but have been reduced over time

As soon as the vaccine was injected my arm hurt through my neck to the back of my shoulder blade. I was immediately feeling woozy and dizzy. I sat for 20 minutes and took a Tylenol. I left the site and about 30 minutes later I was feeling extremely tired, and out of breath. Talking was difficult and taking too much energy, my shortness of breath was alarming. It went away within 4 hours. 2 days later I was feeling fine, and was sitting having a coffee. Out of nowhere I had a rapid heartbeat and started feeling woozy and light headed again. I didn't have as much shortness of breath but it felt like if I were to try and do anything it would exhaust me. I took Tylenol again and things calmed down in about 2-3 hours.

Weakness in hands, feet and legs; Facial numbness and drooping 30 mins after injection; Facial numbness and drooping 30 mins after injection; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization at age 26 years old. The patient was not pregnant at the time of vaccination. The patient had covid prior to vaccination. No known allergies. Patient was not tested post vaccination. There were no concomitant medications. No other vaccines in four weeks and no other medication in two weeks. On 12Mar2021 14:30, 30 mins after injection, the patient experienced facial numbness and drooping 30 mins after injection. On 13Mar2021 02:00, weakness in hands, feet and legs starting 12 hours after injection. Treatment was not given for events. The patient had not recovered from the events. Information about lot/batch number has been requested.

Shortness of breath; chest tightness; stated that she got the first shot in her left hip; soreness to left hip; burning at her left hip; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received BNT162B2 first dose (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 14Jan2021 at 16:20 (Batch/Lot Number: EL3249) as single dose, then via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included rotator cuff injury from 2020, unknown injury from 2018 to 2019 and repeated injuries to her shoulder (occurred before the vaccine) from an unknown date and unknown if ongoing. The concomitant medication was not reported. The reporter stated that she is a healthcare worker with repeated injuries to her shoulder that occurred before the vaccine. Stated that she had rotator cuff surgery in 2020 and the another injury 1-2 years prior to that one. Stated that the first booster that she received was three weeks ago in her hip on 14Jan2021 16:20. Stated that she went to get the second dose today in her thigh. Stated that she was told that it was being given in her thigh because it was conclusive to being effective. Stated that she was told that the first dose may not be effective. Wanted to know the current information where it should be administered. Wanted to know if she should get first dose again. Clarified that the booster is for the Pfizer Covid 19 vaccine. Stated that she got the first one on 14Jan2021. Stated that she gets repeat vaccines every year and had a declination to IM sites to the shoulder/arm area due to her injuries. No further details provided. Later clarified first booster was to her left hip. The reporter stated that with the first shot that she had soreness to left hip and burning at her left hip on 14Jan2021 16:20. Stated four days after the vaccine that she did a lot of cardio and had chest tightness and shortness of breath on 17Jan2021 16:00 within 10 minutes after that lasted for an hour. Stated burning only lasted 15 minutes. The outcome of the events the first dose may not be effective due to being given in her left hip was reported as unknown. The outcome of the events stated that she got the first shot in her left hip and burning at her left hip reported as recovered 14Jan2021. The outcome of the events soreness to left hip, Shortness of breath and chest tightness was reported as recovered 17Jan2021.

she started feeling more severe neck pain; swollen lymph nodes on her left collar bone and neck area; This is a spontaneous report from a contactable consumer, the patient. A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL0142), via an unspecified route of administration, in the left arm on 27Jan2021 16:00 (at the age of 26-years-old) as single dose for COVID-19 immunization. The patient medical history reported as none. The patient had no History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient concomitant medications reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously recived first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL1284, Expiration Date: Unknown), via intramuscular route of administration, in the left arm on 06Jan2021 2:30PM (at the age of 26-years-old) as single dose for COVID-19 immunization. The patient did not visited to emergency room or physician office. The patient did not underwent lab test. It was reported that the had vaccine last week 27Jan2021. 3-4 days later she started feeling more severe neck pain, like it hurt to move her neck and head, and then the next day she noticed swollen lymph nodes on her left collar bone and neck area." It was questin was this normal. She said she read online where some people experienced swollen lymph nodes in the armpit area on the left side. She said she didnot see anything about swollen lymph nodes above the collar bone area. Caller asked if BNT162B2 vaccine was causing her swollen lymph nodes, and if so, how long should she expect the swollen lymph nodes to last. No treatment was received for the swollen lymph nodes on my left collar bone and neck. Outcome of the event swollen lymph nodes on my left collar bone and neck area was not recovered and unknown for other event.

3 days after receiving the Pfizer COVID-19 vaccination, the patient reported numbness in her bilateral toes that progressed to numbness and weakness of her bilateral legs. 5 days after the onset of her initial symptoms, the patient noted bilateral numbness in her fingers and her mouth, that also progressed to weakness in her bilateral arms. A few days later, the patient noticed a right-sided facial droop that brought her to the ED. Given the patient's symptoms and elevated protein in the patient's CSF (obtained via lumbar puncture), the patient's symptoms are concerning for Guillain-Barre syndrome. The patient was started today on 5 days of immune globulin (PRIVIGEN) 10 % IV infusion 25 g.

patient with bilateral posterior knee pain, bilateral Achilles tendon pain, and left fourth toe pain. These were severe enough to cause inability to walk

Severe headache, sinus congestion, dizziness, nausea, diarrhea, heavy menstrual period, fatigue, drowsy, muscle pain, injection site soreness

Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for greater than 72 hours Headache for 72 hours

I woke up with significant right-sided facial and eye swelling currently still present although improved in severity. Other symptoms included pain/heat at injection site, myalgias, fatigue.

The Sunday after I received the vaccine I had increased hip pain and Sunday night I had a rash anon the L2 and L3 dermatome. I thought it was shingles and made an appt. Overnight the rash spread and it was very painful, On Monday I got Volcite for 7 days and I still have rash (improving) and pain today.

received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00

Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, "burning up" no fever, headache, back pain, palpitations, left axillary lymph node (peach pit size) bilateral inguinal pain next day. Symptoms improved

12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Reports the rest of the day felt tachycardiac for a few hours (HR 120-140) and dizzy. Started getting muscle aches/joint aches. Denies any recent COVID exposure. Tested positive for COVID In 8/2020. Reports hips/knees are throbbing today; Heart rate WNL. /// Presenting today due to intermittent presyncope and palpitations. Also notes generalized weakness. Patient evaluate 2 L of fluid given her Mirena IUD D-dimer was sent which was negative patient with no pleuritic symptoms or dyspnea to suggest pulmonary embolism. Otherwise hemodynamically stable on exam ambulates with no difficulty no focal neurologic deficits. Patient did describe on her initial presentation that she noted some weakness of her bilateral legs. Given her possible viral reaction and description of weakness it is possible the patient is developing an early autoimmune reaction however she has no evidence of GuillainBarré or transverse myelitis on my exam. We will plan to discharge with neurology follow-up as outpatient.

I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild headache, muscle aches and felt the cold shivering feeling but had no fever.

Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.

Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.

sore injection site the next day, next day at 10am began experiencing aches in my joints and achey muscles all over, mild headache, fatigue. At around 1pm experienced chills and fever. Experienced 3 episodes of diarrhea that started about 5 hours after the vaccine.

Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days later I had an area of papules on my anterior thigh the size of a half dollar. The right sided back pain then began to radiate around to my hip and the rash began to be painful. My right thigh eventually began to tingle and and the pain increased in severity. On Jan 7th I presented to the acute care clinic at the Clinic and was diagnosed with shingles.

Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021

Severe body aches and chills. High grade temperature. Fatigue, extremely tired, joint pain. Symptoms particularly reduced with ibuprofen 600 mg

Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. About 24 hours after the 2nd dose, I noticed the area around my left collar bone was swollen . The area is painful to touch and contains a lump about the size of a dime. Pain is experienced when I attempt to cross my left arm over my body. Lump and pain still remains 51 hours after vaccination.

I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.

12/22 vaccination. Within a few minutes, after sitting down, I started to get really dizzy, lightheaded. Intermittent chills. Symptoms lasted 20 minutes. 12/23 24 hour post vaccine, symptoms returned. myalgia. Temp was higher then normal baseline; 99.4. 12/24 still had dizziness. called employee health; mild / moderate reaction to vaccine. Tylenol. Dizziness resolved. 12/25 symptoms resolved. Following Monday, afternoon, felt extremely fatigued. Touched base with COVID committee; UPMC/advised to get titers checked.

Myalgia & Fever Narrative: Pfizer covid 19 mRNA given 1/4/2021 left arm vaccination site (IM) at 1:17 pm complained of muscle soreness Left arm 09:00 pm 1/4/2021. The next day - morning felt tired, muscle soreness, Headache esp bifrontal and retrobulbar. T 99.7 taken this morning and took Ibuprofen 600mg one tablet this morning. She still reported for work today but complained about these symptoms to Supervisor who consulted EOH providers Denied cough nor colds nor any upper respiratory symptoms A/P: Vaccine related side effects within 24 hours after vaccination Reported to facility admin Can return to work if she feels better tomorrow but without taking analgesics (ibuprofen) nor antipyretics (Tylenol) Informed Supervisor

lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious. Information on the Lot/Batch Number has been requested.

Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.

chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection took 650mg tylenol, able to fall asleep awoke again with sweats (did not take temperature) able to fall asleep, slept a total of 18 hours still with headache, weakness, fatigue on wakening, took 325 mg tylenol and 200 mg advil symptoms resolved approximately 25 hours after injection

Symptoms that began at 10pm the night I reviewed the vaccine included chills, fever, body aches. This lasted till about 2am. Finally fell asleep and woke up at 8am very sore but much better. Around 3:30pm I started again with the same severe chills, fever, body aches and now nausea. Woke up in the middle of the night drenched in sweat. The following morning I woke up around 8am again with horrible mid/lower bilateral back pain. This lasted till about 1pm. It?s not 9pm and all symptoms have subsided. I feel hopeful, thanks for all you do!

Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.

Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle aches. 12/23-1/9 (present) 2 virtual dr visits, recommended Tylenol and rest

side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by fever and muscle aches. Highest fever was 101.7 F. side effects were bad enough to affect ability to do ADLs and to be able to go to work. Swollen lymph node in left clavicle since first dose got bigger and firmer. since symptoms have resolved swollen lymph node still there.

I woke up the morning after my shot and I had some pain around my left clavicle when putting pressure on it (turning in bed, etc. ) and I felt around and there was a small lump. Seems like a swollen lymph node. Today (2 days later), the area is more tender and a little larger upon palpation.

24 hours after the 2nd vaccine on 1/7/21, I began experiencing joint pain in bilateral hands, fingers, thumbs. Worsened over the next few days. Created difficulties with grip. Took ibuprofen, and applied heat/ice. General fatigue as well. Still recovering as of today 1/10/21.

Chills, moderate body aches that made it difficult to work, joint pain. Improved with ibuprofen/naproxen

Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***

14 minutes post injection, patient laid head on table and started shaking. Complained of severe headache, h ands, arms and legs numb. No resp problems. 7:50am given 12.5mg of Benadryl IM. 0800 shaking slowing down, but headache, tinglig in arms, legs still numb. 8:04another 12.5 mg of Benadryl IM given. 8:15 shaking stopped but headache continues. Legs remain "heavy" but arms normal. Patient complains of copper taste in mouth. 8:20 legs mostly back to normal. 8:30 able to walk with no symptoms at this time except for headache. Husband arrives to take patient home.

Myalgias, arthalgias, and headache starting at 12 hours after vaccine. These lasted 24 hours. Fever, chills, and nausea starting at 22 hours after vaccine and lasted for 14 hours. L axilla lymphadenopathy starting 38 hours after vaccine. Treatment was tylenol and ibuprofen prn.

Heaviness and tingling in bilateral arms. No other symptoms. She was monitored for a total of 60 minutes. No decrease or increase in feeling. She called her mother to come and pick her up. She was escorted out of the clinic walking.

Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain like cramps and pins and needles if skin rubbed, joint pain, sharp brief headache that comes and goes in random spots of head, fatigue, malaise, mental fog

patient states that she received vaccine on 11/11/21 at 10 am and symptoms started on n11/11/21 at 11 pm and included: fever of 100.4 degrees Fahrenheit-relieved with tylenol, headache, body/muscle aches, chills, sore throat

Pfizer-BioNTech COVID-19 Vaccine EUA: 1. Injection site tenderness x 2-3 days, no treatment 2. Fatigue, severe headache, muscle pain, fever x 8-10 hours (started about 10 hours after getting the vaccine), Tylenol

developed hives on arm along with fever, chills and muscle aches. Self treated and symptoms resolved

Normal pregnancy other than anemia of pregnancy, EDD 02/18/21. Woke around 0030 with rigors, temp 103.5F, muscle aches, joint pain. Fever resolved with 1000mg Tylenol and hydration. Fevers continued with Tmax 102.5 for next 24 hours. Muscle aches, joint pain, headache, and fatigue persisted for about 36 hours total.

muscle and joint pains that got progressively worse over the next 24 hours; muscle and joint pains that got progressively worse over the next 24 hours; body pain/body aches; I also have shaking chills; throbbing headache; tender anterior cervical lymphadenopathy; runny nose; dry cough; chest tightness; First dose of bnt162b2 on 18Dec2020/ second dose on 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient (pregnant: No) received of bnt162b2 (Pfizer), via an unspecified route of administration in left arm on 04Jan2021 07:15 at single dose (second dose), via an unspecified route of administration in left arm on 18Dec2020 12:30 at single dose (first dose dose) for COVID-19 immunization. Medical history included asthma, allergies from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. Around 12 hours after the second dose, the patient started feeling muscle and joint pains that got progressively worse over the next 24 hours. She had to miss 1 work day so far due to body pain despite alternating taking ibuprofen and paracetamol (APAP) around the clock. It was now 48 hours after the vaccine, and she still have severe body aches. She also had shaking chills, throbbing headache, tender anterior cervical lymphadenopathy, runny nose, dry cough and chest tightness. Of note, she was a healthcare worker and tested negative for COVID PCR immediately after she received my second dose of the vaccine. She was tested due to a low-suspicion possible workplace exposure 5 days prior. She had no symptoms before the vaccine. The patient underwent lab tests and procedures which included nasal swab test: negative on 04Jan2021. The events were reported as non-serious. The adverse event didn't result in emergency room visit or physician office visit. No treatment received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Birth control pills. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the had patient been tested for COVID-19. The outcome of events was resolving. Information about lot/batch number has been requested.

Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This is a spontaneous report from a Non-contactable Other Health Professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunization. Medical history reported as none. Known allergies: NO (Allergies to medications, food, or other products: No). The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination: No. The patient experienced Fever, body aches, joint pain, headache, diarrhea, dizzy spells, uncontrollable shakes, chills, all on 06Jan2021 21:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. No treatment received for the adverse event. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Covid test post vaccination: Nasal Swab on 07Dec2021 with result negative. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fatigue. Sore injection site, tender to the touch. Moments of Dizziness and zoning out.

Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, my HR went to 180, my legs felt weak, I was having chest palpitations and chest pain. I felt really dizzy and nauseated, I felt like I could not walk. I felt like I hit by a bus. The next day I had heavy flu symptoms, high fever, continuous chest pain and high HR, at the ER they gave me a high dose of Benadryl, steroids and fluids. I took Benadryl for about 7 days and I still felt light headed palpitations and fever for almost 2 weeks. I also was tested for COVID and it was negative. I was advised to not take the second vaccine. I still have a really bad fatigue. It is the symptom that is still on and off.

Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection site, body chills, body aches and a fever of 102 F. Symptoms subsided after Motrin was administered (in about an additional 8 hours to recover fever). Body aches, pain at injection site and lingering headache still present 24 hours after vaccination.

rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over; a lot of muscle pain; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 24Dec2020 09:30 at single dose for preventative. Medical history included none. There were no concomitant medications. The patient previously took influenza vaccine (FLU) for immunization and experienced sick (Flu shot if it contains egg she gets really sick). Patient reported experiencing a rash 2 weeks on 06Jan2021 after getting her first dose of the vaccine. Caller stated ''I'm concerned because I'm getting this rash on my face and everywhere and I'm due for my booster on 13Jan2021." Caller questioned if others had reported this. She had a lot of muscle pain on 24Dec2020 and could not sleep from the pain in Dec2020. Reports the pain is gone now and lasted till 28Dec2020. She has a rash and it is breaking out her face and now it is all over. States nothing has changed and the vaccine was the only new thing. States the rash started two weeks since she got the vaccine. Vaccination facility type was Hospital. Vaccine administered at military facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE not require a visit to emergency room. Therapeutic measures were taken as a result of rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over (Doctor ordered steroids for her today she is a CNA). The outcome of the event a lot of muscle pain was recovered on 28Dec2020. The outcome of the event rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over was not recovered. The outcome of the event could not sleep was unknown. Information about lot/batch has been requested.

Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. She has been having fever, muscle aches, arm pain and chills.

Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my neck for about an hour. As well as left sided facial pain. Worst migraine of my life. Right leg/foot spasms. Heart palpitations, difficulty catching breath, Following day-moderate neck pain, headache, and very sore left arm, nausea, left shoulder pain

Onset 12 hours after injection of alternating fever and chills, nausea, vomiting, myalgias, arthralgia, and headache.

Fever, sore throat, chills, congestion, cough, nausea, muscle aches, tachycardia. Treatment: Tylenol with no improvement Outcome: referred for COVID testing

Fever; myalgia; malaise; This is a spontaneous report from a contactable Physician (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), intramuscular (vaccination location: left arm) on 18Dec2020 13:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included COVID-19 (reported as prior to vaccination, patient was diagnosed with COVID-19) from an unknown date and unknown if ongoing. The patient has not received other vaccines within four weeks prior to COVID vaccine and no other medications received within two weeks of vaccination. The patient's concomitant medications were not reported. The patient has no known allergies. On 19Dec2020, the patient experienced fever, myalgia, and malaise. It was reported that patient received paracetamol (TYLENOL) for fever. It was reported that since vaccination, the patient has been tested for COVID-19 with PCR swab test on 28Dec2020 which had negative results. Outcome of the events was recovered. Information on the Lot/batch number has been requested.

felt numbness at the injection site; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; Throughout the day (Dated) it became increasingly difficult to turn my head in any direction and is very painful to move it to the left; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration from 06Jan2021 14:15 (reported as "02:15 PM") at single dose on the left arm as COVID vaccine. The COVID-19 vaccine was administered in a workplace clinic. Medical history included gastrooesophageal reflux disease (GERD), Acid Reflux Disease, Pseudo Tumor and known allergies reported as "Known allergies: Sulfate Drug, Pertussis". The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient reported that directly after the shot, she felt numbness at the injection site and stated "I realize this is normal and the shot was given properly and painlessly in the upper left arm) at approximately 2 am (12 hours after receiving the vaccine)". Patient woke up with moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line. Throughout the day on 07Jan2021, it became increasingly difficult to turn her head in any direction and was very painful to move it to the left. The events occurred on 07Jan2021 -2:00 AM. Events were assessed as non-serious. No treatment was received for the events. No Covid prior vaccination. The patient was not tested for COVID after/post vaccination. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp contacted employee heatl

the day after woke up with a headache and muscle pain that continued to last. for the last two weeks I have also had tachycardia and extreme fatigue, on top of the muscle pain and headaches.

Patient developed a feeling of heaviness of her left leg and left arm after approximately 30 minutes after vaccine administration. Her tongue became numb. Temperature was normal @ 98.2 F.

Pfizer-BioNTech COVID-19Vaccine EUA Low-grade fever, chills, myalgia beginning around 8:00PM on the evening of vaccination. Symptoms resolved by morning.

Pfizer-BioNTech COVID-19Vaccine Side effects of chills, low-grade fever, myalgia began at 6:00 PM on the evening of receiving a vaccine. Side effects were subjectively worse than after first dose (12/22/2020). Side effects continued the following day and night and resolved two days later on the morning of 1/14/2021.

profound headache; resembling meningitis: could not turn neck from side to side; resembling meningitis: could not turn neck from side to side; pressure behind eyes when moving eyes quickly; profound body aches, primarily in the lower back; profound body aches, primarily in the lower back; 100.2-101.0 fever; chills; lethargy; This is a spontaneous report from a contactable Nurse reported for self. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:30 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included influenza vaccine inact split 4v (AFLURIA QUAD), desogestrel, ethinylestradiol (APRI). The patient experienced profound headache, resembling meningitis: could not turn neck from side to side, pressure behind eyes when moving eyes quickly. -profound body aches, primarily in the lower back. -100.2-101.0 fever -chills -lethargy on 10Jan2021 12:00. Patient had Rapid nasal swab with negative result on 26Oct2020. Outcome of events was recovering.

Lightheadedness Fever, despite Tylenol (101.3) Muscle pain - primarily in lower back and quads Joint pain - ankles, knees, hips

When I went to get the shot, I had a firm bump with what looked like a white head on my left arm from the first shot. When she injected the 2nd dose, the bump was painful and grew twice in size on my arm and started bleeding. The technician rubbed the area for a fews minutes and the swelling went down. The bump went down, but the whole day, I felt a little sick. At around 7pm, I felt feverish, with muscle aches and chills. My skin was sensitive to touch, I felt nauseous, and I could barely walk. The bottom of my left eyelid also became a little swollen. The symptoms resolved the next morning.

General fatigue; Joint pain (specifically isolated to my bilateral hands, fingers, thumbs) caused difficulty with gripping objects; This is a spontaneous report from a non-contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 07Jan2021 17:15 at a single dose on Left arm for COVID-19 immunization. Medical history included depression, anxiety, chronic sinusitis, and allergy seasonal /pet dander. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), bupropion hydrochloride (WELLBUTRIN), asa (ASA), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA). The patient previously took Ceclor, Sudafed and experienced drug allergies. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 17Dec2020 18:15 at a single dose on Left arm for COVID-19 immunization. The patient experienced general fatigue and joint pain ("specifically isolated to my bilateral hands, fingers, thumbs") caused difficulty with gripping objects on 09Jan2021 13:00 ("01:00 PM"). No treatment received for events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment not received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Arm pit sore - to injection site, warm to touch, red area, tender to touch, swollen denies any fever Started on abx - cephalexin

almost had syncopal episode from weakness; almost had syncopal episode from weakness; after my second dose, I had no until hour 12. I woke up middle of night to severe fatigue; myalgia; low grade fever; headache; swollen lymph node in L armpit; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; This is a spontaneous report from a contactable physician reporting for herself. A 27-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not reported) on 08Jan2021 14:00 via an unspecified route of administration in the left arm for COVID-19 immunization. There was no other relevant medical history. No unknown allergies. The patient previously received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not reported) on 19Dec2020 12:00 pm in the left arm for COVID-19 immunization and experienced some arm pain which lasted several hours and mild. Concomitant medication included sertraline, ascorbic acid (VIT C), ergocalciferol (VIT D), zinc, cetirizine hydrochloride (ZYRTEC). No other vaccine was received in four weeks. The patient had not had COVID prior vaccination, and COVID was not tested post vaccination. After the second dose on 08Jan2021 at 02:00 pm, the patient had no symptoms until hour 12. On 09Jan2021 at 12:00 am she woke up middle of night to severe fatigue, myalgia, low grade fever, headache, swollen lymph node in left armpit (injected left arm). On 10Jan2020, the patient was 36 hours out and she still had these symptoms but slowly improving, relieved more with ibuprofen vs paracetamol (TYLENOL). She also reported she did not receive treatment for the events. She stated that the myalgia, fatigue, headache were severe and she almost had a syncopal episode from weakness. The events were non-serious as reported. The outcome of the events was reported as not recovered.

injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.

Severe pain in temples and jaw, pain at hips, nausea and vomiting, low-grade fever (highest was 100.1 degrees F), dizziness.

I had side effects (fevers, myalgias, headaches) the day after. However, starting Saturday 1/9 I began having urticaria all over my body. I took Benadryl 4 times over the course of the day, and the rash goes away but comes back. Went to Urgent Care on Sunday. Advised to take Benadryl and Pepcid

low grade fever of 99.4; sore joint pain on my knuckles and my wrist; felt kind of off and weak; felt kind of off and weak; Arm was a bit sore for 3 days; mild headache; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 20Dec2020 16:15 at a single dose for covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient is not pregnant. Concomitant medication included fluoxetine taken from an unspecified date for an unspecified indication. On the second day of the vaccine (21Dec2020 10:00), the patient had a low grade fever of 99.4 (no unit reported), had sore joint pain on her knuckles and her wrist, felt kind of off and weak, her arm was a bit sore for 3 days and she also had a mild headache that would come and go. No treatment was received for the reported events. The outcome of the events was recovered.

Mild headache, mild dizziness, fatigue, moderate joint and muscle pain mainly in neck, shoulders, upper extremities. Currently managing with rest and did not seek medical care.

flu; HR was higher than normal; fever; felt weak; dry cough; headache; muscle and joint pains; muscle and joint pains; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the second dose of bnt162b2, intramuscular in the left arm, from 12Jan2021 09:00 at SINGLE DOSE for covid-19 immunization. Patient was not pregnant at vaccination. Medical history included GERD (gastroesophageal reflux disease) and barrett's esophagus. Historical Vaccine included 1st dose of BNT162B2 on 24Dec2020 via intramuscular in the right arm for COVID-19 immunization. Concomitant medications included melatonin, pantoprazole sodium sesquihydrate (PROTONIX), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS), and algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON). On 13Jan2021 03:00, the patient felt like she had a flu; her HR was higher than normal, felt like she had a fever, felt weak, developed a dry cough, headache; and muscle and joint pains. The outcome of events was recovered. The patient did not receive any treatment for the events. Information on the lot/batch number has been requested.

fever; pulsating migraine; joint and muscle aches and pains; joint and muscle aches and pains; dizziness; fatigue; First dose on 21Dec2020, second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular at Left arm on 06Jan2021 15:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included swine flu. Concomitant medications included buspirone, venlafaxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), ethinylestradiol, levonorgestrel (AVIANE) for birth control, plantago ovata fibre (FIBER SUPPLEMENT), probiotics and women's multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's historic vaccine included first dose of BNT162B2 (lot number: EL0140), Intramuscular at left arm on 21Dec2020 15:15 for covid-19 immunization. On 07Jan2021 11:00, the patient experienced fever, pulsating migraine, joint and muscle aches and pains, dizziness, fatigue - absolutely could not have went to work if she was scheduled that day - just moving from her left side onto her right side took immense effort and tears - haven't experienced anything like it since she had swine flu. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events fever, pulsating migraine, 'joint and muscle aches and pains', dizziness, fatigue was recovered on an unknown date in Jan2021.

I was asymptomatic for about 6.5 hours after the vaccine was given. At about 6pm on the day I received the vaccine I noticed some injection site tenderness, minimal swelling; has been present since. Symptoms are very mild. I started having chills and hot flashes intermittently, more hot flashes than chills, have been present since 6pm yesterday. About 9pm I had a headache, muscle aches, joint pain as well. I felt feverish but temperature was 98.6F. I also noticed some axial lymph node swelling as well on the Left side where I received the vaccine. Tender to touch, not too painful though. Since received the vaccine I have had intermittent dizzy spells as well all throughout the day. I decided to go to sleep at 10:30pm and all night I tossed and turned with a headache and hot flashes. I woke up at 7:30am and was so stiff I could barely get out of bed. I called into work as I could not stand up without have dizziness. All day so far I have had dizziness upon standing, headache, myalgia, arthralgias, hot flashes/felt feverish, swollen axial lymph nodes and all I have wanted to do today is sleep. I took a nap and when I woke up I had been sleeping for 6 hours. I finally was able to get up and drink a 32ounce cup of water and take some ibuprofen. Ate some cereal. I still have a headache and dizziness upon standing that limit my ability to do normal daily functions.

Fever (103 lasting a day and a half); Nausea; Chills; Muscle aches and soreness; Malaise; Lymphadenopathy; Arm/under arm/pec soreness in vaccine arm; Fatigue; Sore throat; Dry cough; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 07Jan2021 07:45 at single dose in left arm for covid-19 immunization. The patient had no medical history and no known allergies. Concomitant medication in two weeks included birth control. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 21Dec2020 10:15 at single dose in left arm for covid-19 immunization. The patient had no other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough on 07Jan2021 19:00. The patient did not receive any treatment for these events. The outcome of the events fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough was recovered in Jan2021. Information on the lot/batch number has been requested.

Sore arm, left axilla pain, body aches, leg cramps, headache, fatigue, neck pain. Started 12 hours after vaccine

First started off with a cold feeling around injection site. Around 11:30 at night I felt muscle aches in my calves. 30 minutes later my legs were having severe muscle aches and joint pain in my ankles. I was having cold chills and aches the whole night along with sweating. On 1/20/2021 (the next day) the muscle aches, chills, and joint pain continued through the whole day. I was nauseous at times and did not have an appetite. Around 5 o clock I felt some relief with my leg pain but it started again around 9 o clock. I continued switching Tylenol extra strength and ibuprofen. I went to bed on 1/20 at midnight with little leg pain but major neck and back aches. I did not have cold chills through the night or sweating. Today (1/21/2021) leg pain is near gone, but joint pain is still there in my left ankle and knee. My legs feel heavy and strange and is causing me to walk slowly because I feel like my legs are very fatigued and off balance. I have had neck and back aches all day. I have not had chills today

Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for Protocol C4591001 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject is in open-label phase of the study when the event occurred. A 27-year-old female with a medical history of seasonal allergies (Mar2006 and ongoing not taking any medications to treat) who received the first dose of blinded therapy (BNT162;PLACEBO) (dose 1) on 14Aug2020 at 10:34, second dose of blinded therapy (BNT162;PLACEBO) (dose 2) on 04Sep2020 at 09:27. The first dose of BNT162B2 (dose 3) on 23Dec2020 at 09:25, and the second dose of BNT162B2 (dose 4) on 11Jan2021 at 09:48. All intramuscularly in the left deltoid as a single dose for COVID-19 immunization. Concomitant medications included ethinyl-estradiol/norethisterone acetate (LOESTRIN) for birth control from May2014 and ongoing. There was no family medical history relevant to AE and no concomitant vaccine administered on the same date of investigational vaccine or other prior vaccine within four weeks. The subject experienced neuropraxia of left arm on 11Jan2021 at 09:51 considered an important medical event requiring a visit to physician office. The clinical course was the following: At 9:51, 3 minutes after receiving the second dose of BNT162B2 in left deltoid, the subject complained of left arm numbness and tingling starting at elbow and extending to fingers, weakness, and a weak grip in that hand. She also reported a decreased range of motion on the left side including her arm, shoulder joint, elbow, wrist, and metacarpophalangeal. Subject was afebrile with a normal vascular exam, no bruising, capillary refill time was less than 3 seconds. No antipyretic medication was administered. The investigator requested the subject to return to site the following day. On 12Jan2021, the investigator noted some improvement to symptoms but the subject was unable to return to work for several days after event. An appointment was scheduled with a neurologist for 13Jan2021. The action taken with BNT162B2 for the event was not applicable. The clinical outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event neuropraxia of left arm was related to the second dose of BNT162B2 (dose 4) and clinical trial procedure (vaccination administration in the left deltoid, investigator did consider the location was appropriate), but unrelated to first and second dose of blinded therapy (BNT162;PLACEBO), first dose of BNT162B2 (dose 3) or concomitant medications. Per investigator, it was not likely that the event was related to the investigational product (IP) itself, however, that could not be 100% determined until neurologist had evaluated the subject.; Sender's Comments: The event "Nerve Injury" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2). There is a reasonable possibility for the event "Nerve Injury" to be related to the procedure of vaccine (BNT162B2) administration (needle trauma) rather than to the product administered. The event would not be considered a unique response to this specific vaccine (BNT162B2). The case will be reassessed upon reception of neurological advice. Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 31-DEC-2020 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Nerve injury. Review of the database for the PT Nerve injury had the following results: 0 serious clinical trial cases and 1 non-clinical trial case. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.

Pt received dose#2 and c/o allergic reaction with faster onset. Pt reported dizziness/neck stiffness and right sided headache, nausea. States feels weak on the right side but no numbness. No slurred speech. No facial asymmetry. Pt denies any SOB/throat tightening. Dizziness less severe this time per patient. She was dizziness for 3 days with dose #1. Patient was discharged at 2112.

12 hours after injection, I experienced fatigue, muscle aches/tension, headache, a low-grade fever lasting approximately 9 hours. Self-treated with ibuprofen. Symptoms were 100% resolved within 24 hours of vaccination.

Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), muscle pain, eye pain, fatigue, fogginess

Fatigue, myalgia, Left supraclavicular lymphadenopathy 24 hours after 2nd Pfizer COVID vaccine. 72 hours (1/22/2021) after developed right supraclavicular lymphadenopathy as well. but smaller than the left one

3AM 1/13 WOKE UP WITH FEVER 12PM 1/13 VOMIT. ALL DAY FEVER, MUSCLE PAIN TOOK TYLENOL 1 GRAM @ 4AM 1/13 12PM 1/13, 10PM 1/13

12 hours after the vaccination, I had fever, chills, headache, myalgias, dry cough, nausea, decreased appetite, nasal congestion.

SEVERE shortness of breath (basically hyperventilating) for 2-3 hours, very sharp pains/heartburn in the chest when trying to take a deep breath, nausea, vomiting, diarrhea, joint pain, fatigue, chills/hot flashes, sudden uncontrollable fatigue (deep sleep for 2-3 hours after)

Started with severe low back pain on 1/20/21 with no reported injury or trauma. Pain is constant and severe 7-10/10. No urinary symptoms. No prior hx of back injury or chronic pain. Has not improved in the last 5 days with ice, heat or ibuprofen.

Systemic: Generalized Body Aches -Mild, Systemic: Other- injection given in left arm and patient complained of muscle soreness of right thigh. Patient had also reported side effects to previous vaccines but did not note it on the consent form.

The only symptom that I noticed was a lot of pain in my joints, especially in my right hand. after three days symptom disappeared.

Severe L arm pain starting the day of injection. Additionally, L arm weakness. Worse pain and weakness for the first week after injection, but pain and weakness still present at the time of submission (>2 weeks from injection)

Developed fever, chills, fatigue, headache and muscle aches roughly 16 hours after vaccination. Fever resolved 10 hours later. No other symptoms the following day.

Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021. Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.

Sore arm for 3 days, chills for 7 hours, and uncontrollable lower back, hip joint, legs and neck pain/ache for 24 hours straight.

Patient reports ~10 minutes post vaccine becoming sweaty, experiencing blurry vision, and muffled hearing. Writers assessment at 12 minutes , no longer diaphoretic, reports clear vision, slight headache, still slightly muffled hearing. Report no past medical history or allergies, and states last meal was ~20 hours ago. Assessment at 20 minutes - patient reports ?weak neck?, continued headache, vision/hearing returned to normal. Provided with education to seek care of physician if conditions continue or worsen, left site with boyfriend.

Myalgias several hours later . Evening worsened myalgias, shivering, "burning up", no fever, headache, back pain, palpitations, left axillary lymph nodes pain, next day "peach pit size", this has improved . bilateral inguinal pain "a week for symptoms to resolve"

Approx 12 hours after 2nd covid vaccine, patient developed myalgias in arm, armpit, neck, progressing to 'large' - 2cm? tender lymph node in left anterior cervical chain with pain radiating to axilla. T max 100.1 on day 2. Pain/chills resolved with NSAIDs. Over the next 14 days, lymphadenopathy slowly decreased in size. On day 14, she presented to clinic with persistent non tender lymph node, 1cm in size, mobile without c/f infection. Expectant management advised. Reaction reported due to duration of LAD; appears to be on average 10 days.

Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as time passed, started hot flashes , cold flashes and shakes around 11am, right kidney (?) area on back started to hurt around 11:30am pain increasing as well. All persistent until about 5:30pm where the kidney (?) pain subdued followed by the hot and cold flashes around 7pm. Nausea and shakes passed by 1/30/21 am after I woke up. Full Left arm pain continued all day 1/30/21.

1/27 , 13 hours after vaccination (dose #2), 2:30am- strong rigors. Temp 102 1/27-1/28 SEVERE pain on the top and back of head, neck pain, and back pain. Pain untouched by consistent 1000mg tylenol and 600mg iburpofen. Also, generalized joint and muscle pain + weakness. I was unable to sit up these days. 1/27-1/29 Fevers for 3 days straight. Unable to get temperature below 99.8 even with Tylenol. Alternated 600mg Ibuprofen and 1000mg Tylenol. 1/28-1/29 Diarrhea - 5-6 bowel movements

Diarrhea; Chills; Fever of 101.8; muscle pain; This is a spontaneous report from a non-contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), intramuscular on 18Jan2021 00:45 at a single dose for COVID-19 immunisation. The patient's medical history included endometriosis and sulfa antibiotics allergy. Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 at the age of 27 years old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 19Jan2021 03:45, the patient experienced diarrhea, chills, fever of 101.8 and muscle pain. No treatment was received for these adverse events. Outcome of the events diarrhea, chills, fever of 101.8 and muscle pain was not recovered. The events diarrhea, chills, fever of 101.8 and muscle pain were considered non-serious. No follow-up attempts are possible. No further information is expected.

Severe headache that made face and neck and arms tingle, stiff neck, pressure in face, head, eyes, neck and arms; bodily aches; fatigue (these symptoms do happen to me occasionally due to pre-existing fibromyalgia, however after the 2nd vaccine dose these symptoms were the most intense I had ever experienced); nausea

Muscle aches; Back/flank pain; Back/flank pain; Headache; Low grade fever; Joint pain; Chills; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the left arm, on 20Jan2021 10:45 at single dose for covid-19 immunisation. The first dose was received on 01Jan2021 09:00, intramuscular on the left arm . Medical history included asthma, depression, and in the midst of getting diagnosed with Sjogerns. Patient was not pregnant at the time of vaccination. Concomitant medication included spironolactone, bupropion, fexofenadine hydrochloride (ALLERFEX) and hair vitamins. The patient experienced muscle aches, back/flank pain, headache, low grade fever, joint pain, and chills on 20Jan2020 17:30. No treatment was received and patient was recovering from the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The events were considered non-serious. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information is expected.

Arm that was injected feels weaker with muscle twitching over 1 week after vaccination; Arm that was injected feels weaker with muscle twitching over 1 week after vaccination; menstrual cycle was lighter and shorter than usual; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 10Jan2021 (at the age of 27 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included GERD. The patient previously received the first dose of BNT162B2 on 20Dec2020 at 02:30 PM (at the age of 27 years old) as a single dose via intramuscular route of administration in the left arm for COVID-19 IMMUNIZATION. Concomitant medications included vitamin D3, cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), and fluticasone propionate (FLONASE). The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021, the patient experienced her arm that was injected feels weaker with muscle twitching over 1 week after vaccination and her menstrual cycle (that is usually regular each month) beginning 17Jan2021 was lighter and shorter than usual. The patient did not receive any treatment for these events. The outcome of the events arm that was injected feels weaker with muscle twitching and menstrual cycle was lighter and shorter than usual was not recovered. Since the vaccination, the patient had not been tested for COVID-19.

By 10am the day after vaccine the fever broke and I was just left with fatigue; 10 hours after vaccine I started with a fever that climbed to 103.3F overnight; This was joined by chills; This was joined by chills and body/joint discomfort as well as headache; body/joint discomfort; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number: EL8982), intramuscular at left arm on 21Jan2021, 08:15 at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, penicillins allergy and COVID-19 diagnosed on an unspecified date prior to vaccination. The patient's concomitant medications included levothyroxine, minerals nos, vitamins nos (PRENATAL VITAMIN), and riboflavin. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK9231) on 30Dec2020, 12:30 PM at left arm for COVID-19 immunization. The patient has not been tested for COVID-19 since vaccination. On 21Jan2021 18:00 (10 hours after vaccine), the patient started with a fever that climbed to 103.3F overnight. This was joined by chills and body/joint discomfort as well as headache. By 10am the day after vaccine (22Jan2021), the fever broke and she was just left with fatigue. No treatment was given for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The outcome of the events were recovering. The events were non-serious.

The next day following the vaccine, I experienced muscle aches, headache, fatigue, febrile temp before taking antifebrile medication at 100.8 F. At the site of injection on my left arm there was a red mark and slight swelling, left arm felt weak and sore. Overall sense of unwell lasted for two days.

Pain at injection site; muscle pain; fatigue; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient (unknown if pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on left arm on 23Jan2021 13:15 at single dose for covid-19 immunisation. Medical history included Migraines with aura, vasovagal syncope, PCOS, environmental allergies/hay fever, eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cefixime (FLEXERIL), ibuprofen (ADVIL), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), inositol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain at injection site, muscle pain, fatigue, dizziness, all on 23Jan2021 1400. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.

chills; body aches; Miss dosed, I reportedly received 0.3 mL of the UNDILUTED vaccine.; Miss dosed, I reportedly received 0.3 mL of the UNDILUTED vaccine.; myalgias; fatigue; headache; fevers/feverish; This is a spontaneous report from two contactable healthcare professionals (one is the patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982, expiry date: 31May2021), via an unspecified route of administration on 20Jan2021 07:30 AM at 0.3 mL, single (0.3 mL of the undiluted vaccine) on the right arm for COVID-19 immunization (reported as "frontline worker"). Patient is not pregnant. There were no medical history. Patient did not have COVID prior vaccination. Patient has no known allergies. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). Vaccine facility type is hospital. No other vaccine in 4 weeks. The patient reported "Miss dosed, I reportedly received 0.3 mL of the UNDILUTED vaccine", she given an undiluted dose of 0.3 on 20Jan2021. The patient had been experiencing some expected symptoms such as fevers, chills, myalgias, fatigue, headache. No treatment was received for the events. It was further reported that one of the nurses gave an undiluted dose of Pfizer 0.3 to an employee (patient). He has filled out the VAERS. The patient was fine. She has experienced normal post vaccination symptoms. She has had chills, body aches on 21Jan2021 and was feverish in Jan2021. They asked "what to do from here? Does she need the second dose?" Patient was told to take Advil, hydrate and rest. The reporter also asked "Have their been any other issues like this? Has this happened before?". Patient did not have a prescribing doctor. It was just an employee vaccination. The nurse who administered it, thought it was already diluted. It was a fresh vial just opened and undiluted, but she thought it was just the last dose in a vial. So she drew up 0.3. It was a miscommunication. Patient got the vaccine at 7:30 am yesterday (20Jan2021). They found this out later because the inventory did not add up. There was an extra vial, but less people were vaccinated. The nurse thought it was diluted already. They called the patient late in the afternoon yesterday around 5:30 or 6 o'clock. She said she was fine. Then, this morning she relayed to her supervisor that she was experiencing normal vaccination side effects. He was looking for more information before he called her again today to check on her. The patient is was a Physician assistant, so she was aware of what to do. She was told yesterday to take NSAID or Ibuprofen. The reporter does not know the seriousness of the events until he gets more information. He does feel like the side effects she was having were normal. Compared to what others have reported. Patient is a front line health care worker. She did work in the ICU during the beginning of the pandemic. She has no listed allergies. She was fully vaccinated because she was a healthcare worker. She has her HepB and MMR vaccines. Outcome of the events chills, body aches and feverish was not recovered (reported as ongoing), for "Miss dosed, I reportedly received 0.3 mL of the UNDILUTED vaccine" was unknown while for other events was recovering. Patient was not tested for COVID post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021064350 Pfizer

Muscle sore and itchy around injection site. No redness. EMS evaluated and removed band aid. Had client do arm stretching exercised and felt better.. BP 120/82 P72 O2 98% lung sounds clear

Within an hour, I was having severe pain in my shoulder. I took off the bandaid and noticed the injection point was way higher than it should have been. I had redness in the area (about 1-1.5 inch diameter) too that I have a picture of to show the injection location. I have limited range of motion, severe pain, and shooting pain down the back of my arm. I am unable to use my arm or lift anything that has any weight to it.

lower back pain, worsened to thighs, spasms developed. Unable to walk, Ketorolac injection, prednison, and flexeril. 2 days later on 12/25/2021, symptoms resolved.

Extreme muscular back pain 18 hours post injection to currently. Pain is associated with right shoulder, neck, and right side of spine which is opposite side from where injection was given.. Almost unbearable and debilitating. I took Tylenol every 4 hours which gave only mild relief

Onset of fever 10 hours after vaccination, resolved by the 24 hour mark. Arm stiffness and lymph node swelling in the left armpit beginning 36 hours after vaccine.

first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day. was diagnosed with modified bells paulsey. with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb. FaceTime with the INT to gather this info

Three days after both doses of the Pfizer Covid 19 vaccine, I experienced hand pain throughout the night that traveled up my forearms. On a scale from 1-10 the pain was about a 7. After the first dose, the pain went away in the morning and I was fine. On the third day after the second dose, I woke up with a rash all over my body and again had pain throughout the night only this time I woke up with swollen hands. It?s now been two weeks since my second dose and I am still experiencing hand pain, though improving. My hands feel sore and tight.

1st dose- left arm pain, especially when lifting arm, starting 6 hours later and most intense at 12 hours later, pain gone in 24 hours; 2nd dose- pain under left armpit/ lymph node, started 24 hours after 2nd dose, ongoing

I received the 2nd dose of the Pfizer COVID-19 vaccine around 9:15 am on 2/23/21. Initially, my only symptoms were injection site soreness and minor swelling. Gradually throughout the day, my entire left arm become more and more sore. By 5:00pm, I felt exhausted and dizzy and was having chills. My temperature was 99.8 degrees Fahrenheit. I took a dose of Extra Strength Tylenol, but felt no change. My joints and muscles began to ache around 6:00pm on 2/23/21 and did not stop aching until around 9:00pm on 2/24/21. During the evening of 2/23/21, my dizziness increased and I felt as if I would pass out any time I sat up or stood. My temperature had returned to 98.2 degrees Fahrenheit by 10:00pm on 2/23/21. I then took a dose of Motrin to help with my soreness. On 2/24/21 from morning until 8:30pm, I had no fever or chills, but still felt exhausted and had minor muscle/joint achiness. I took 3 doses of Motrin on 2/24/21 to help with the soreness. Throughout the day, I had some difficulty breathing (felt like a mild asthma attack) and used my emergency inhaler once. At 8:30pm on 2/24/21, my temperature was 100.5 degrees Fahrenheit. I took another dose of Motrin and went to sleep. Around 3:00am on 2/25/21, I woke up drenched in sweat, but feeling better. My temperature was normal then. When I woke up at 7:00am on 2/25/21, I no longer felt achy, dizzy, or tired. I still feel (now at 1:30pm on 2/25/21)as though my asthma is aggravated, but am not having difficulty breathing.

Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.

Persistent and painful lymphadenopathy in left armpit that started T+36 hours after vaccination. At 7 days after administration of the vaccine, lymphadenopathy in left armpit persists and remains painful. At 7 days post vaccination a 2 inch patch of swollen skin appeared at the injection site. This is accompanied by redness, itchiness, and pain.

Fatigue - 4 PM - 02/26/2021-Present Nausea - 5 PM - 02/26/2021-Present Headache - 5 PM - 02/26/2021-Present Inject Site Soreness - 5 PM - 02/26/2021 Increase in Abdominal pain - 5 PM - 02/26/2021-present 101.2 Fever - 5 PM - 02/26/2021-02/27/2021. Lowered to 100.1 2/28/2021-present. Muscle aches - 6 PM - 02/26/2021 - lasted through the night only Dizziness - 10 PM - 02/26/2021-present Dry throat and mouth/unquenchable thirst - 10 PM - 02/26/2021-present Loss of voice (no sore throat) - 11 PM - 02/26/2021 Heart racing - 02/27/2021 since waking up - lasted about 30 hours Rash on left shoulder and arms. Itchy. 2/28/2021 - 9 AM to present

Headache, Cold sweats, flushing, weakness, painful joints, extreme fatigue starting 2 hours post vaccine lasted 24 hours All symptoms have subsided except for worsening constant headache and joint pain more than 2 weeks post vaccine.

UNKNOWN COVID VACCINE BRAND; chief complaint of generalized body aches and increased heart rate onset today. Per the patient, symptoms are beginning in the context of having received the second dose of her COVID-19 vaccine. Patient reports similar symptoms after her initial dose; however, these resolved shortly after. Patient states that she went to an urgent care for her symptoms but was sent to the ED for further evaluation. Back pain is describes as achy and constant.This initially began at the injection site but began to involve the back. Patient reports taking Tylenol around 1000 today without improvement in symptoms. Administered acetaminophen, magnesium (hypomagnesemia), 1 L NS bolus

Pt states "I received my second covid vaccine at 3:30pm on 02/25/2021 and I started feeling really tired about 20 minutes later at approx. 3:50pm. I started getting really hot and sweaty. I had my temperature taken and it was fine 97.6. My chest turned really red, and I got really sleepy. By the time I got home at 5:00pm my temperature was at 99.0. I had a headache, muscle aches all over, and chills. That evening my temp was 99.6. I took 500mg Tylenol around the clock. It hurt to move and to get up to go to the bathroom. The body aches have went away but I am still feeling really fatigued today 03/02/2021. I don't feel 100%."

Shortly after receiving vaccine in left deltoid, pt complained to numbing and pain near the left shoulder. After a few minutes pt stated numbness had moved down arm and left hand was slightly darker than right hand and wrist. Pt was advised to stay in store for observation. After 20-25 minutes the pt stated that numbness has subsided and pt's left hand/wrist had returned to similar color as right hand/wrist. Pt stated that she felt much better and would leave. Pt was advised to contact pharmacy if numbness returned or if arm was tingly, or if pt had any further questions.

First day: chills, headaches, muscle aches, joint aches, second day: itchy rash on hands, feet, and breasts, itchy eyes and nose, sneezing

Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+ hours as well.

Pain in left arm near injection sight; pain when pressed or when arm raised and using the muscles in that area. Slight tickle in back of throat.

First, I had moderate pain in my right arm and near the injection site. After the first dose, my right arm and hand became numb with loss of feeling or touch. This lasted for most of the evening, about 12 hours after vaccination. The injection site and the muscle were in a lot of pain, which climbed up into my neck muscle. I did not have any fever or chills. For the past several days, I have become fatigued very easily. Lastly, my lower abdominal area has become sore with discomfort. I have never experienced this before, and I am not currently menstruating either. Tylenol makes it better, and resting on my back and excess movement makes it worse.

I thought I had Covid-19 and needed to see a doctor because of a dry cough. My chest was tight and it was hard to breath. I had a fever of 100.3. I was prescribed an Albuterol inhaler and Tessalon(suppressant). I had been taking Nyquil every night and round the clock Tylenol and Ibuprofen. I had full body fatigue and terrible body aches. My muscles hurt. A few days later my fever was down and I was having chest tightness. I tested negative for on the rapid test on the 10th PCR test negative repeated that same week and negative. I felt bad for nine days after vaccination. I was still exhausted for another week at work. I got the second dose and had no problems.

Headache, low-grade fever, nausea, and muscle aches began a few after injection and continued until about 72 hours after injection

lymph node pain; pain under armpit of arm where vaccine was given; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number 9262) via an unspecified route of administration on 15Feb2021 at 08:45 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma and high triglycerides. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included montelukast sodium ("SINGULAIR, MYLAN") from an unspecified date for an unspecified indication. The patient previously received dose 1 of BNT162B2 (lot number 9266) on 25Jan2021 at 08:45 for COVID-19 immunization and experienced pain at injection site/left arm, pain when raising arm. The patient previously received cephalosporins on an unknown date for an unknown indication and experienced allergy. Twenty-four hours after the second dose of BNT162B2 on 16Feb2021 at 09:00, the patient experienced lymph node pain and pain under armpit of arm where vaccine was given. The events were reported as non-serious. The patient was not hospitalized due to the events. The patient did not receive any treatment for the events. The outcome of lymph node pain and pain under armpit of arm where vaccine was given was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Fever on day 1 after the vaccine 102 Ongoing headache still Fever on day7-9 ranging from 101-103 with tyelonol neck ache day 7-9 Sore throat day 7-9 Ear ache day 7-9 R arm weakness day 7-9

Fever (100.4) 24 hours after injection, severe headache starting two hours after injection, joint ache, muscle ache, fatigue, chills, sore throat (starting 6 hours after injection) Took advil 8 hours after injection; plan to take another dose of advil.

Pfizer-BioNTech COVID-19 Vaccine EUA Muscle cramping two weeks after shot. Felt similar to menstrual cramps, but in absence of a period (two weeks before period is due, not pregnant). Charley horse cramps. lasting muscle soreness the day after. Pain traveled around but was primarily in hip joints and pelvis.

Soreness at injection site started 3 hours later. Fever over 100F, aching muscles, nausea, fatigue, headache all started at 7am the next day.

fatigue; headache; chills; muscle aches; lymph node swelling; injection site pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) via unknown route of administration on 25Jan2021 02:00 PM at single dose in right arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history included Anxiety/depression, high cholesterol. Patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was reported as none. Concomitant medications the patient received within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL), loratadine, melatonin, norethisterone (ERRIN birth control). It was reported as in addition to the side effects of fatigue, headache, chills, and muscle aches, I experienced lymph node swelling lasting over a week as well as injection site pain which is still occurring and all on 26Jan2021. No treatment received for the adverse events. Since the vaccination, the patient had been tested for COVID-19. Patient underwent labs and procedure included PCR (Polymerase chain reaction): Negative (Nasal Swab) on 26Jan2021. The outcome of event injection site pain was not recovered, while for all other events was unknown. No follow-up attempts are possible. No further information is expected.

Fever up to 102 for 2 days and periodically for 2 weeks after bone ache for first two days and a severe flare up 2 weeks later diarrhea for first week Chills for two days and off and on after Brain fog ongoing since shot

she gave it down towards her knee on her leg; injection was very painful/some burning during the injection; injected the area swelled up as she gave it and became red; injected the area swelled up as she gave it and became red; had a flare for the past couple of days/pretty bad flare/ put her into a flare/ Feeling really bad; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen , license party for etanercept (ENBREL). This non-serious solicited report was reported to Amgen on 05Apr2021 by a consumer from a commercial program and involves a 27 year old female patient who gave it down towards her knee on her leg (PT: product administered at inappropriate site), injection was very painful (PT: injection site pain), injected the area swelled up as she gave it and became red (PT: injection site swelling and PT: injection site erythema) while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on 04Apr2021. On 04Apr2021 last night, the patient took her first injection of Enbrel last night and when she injected the area swelled up as she gave it and became red. The patient reported injection was very painful and she recounted that she gave it down towards her knee on her leg. On 05Apr2021 same day of this report, the patient reported it was sore but no longer red. The patient was referred to HCP and arranged for an in home patient training for next injection. No treatment information was received. The outcome of the event injection site pain was reported as not recovered/not resolved. The outcome of the event injection site erythema was reported as recovered/resolved. The outcome of the events product administered at inappropriate site, injection site swelling were reported as unknown. The event injection site erythema was resolved on 05Apr2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain, injection site swelling and injection site erythema. The causal relationship between the events injection site pain, injection site swelling, injection site erythema, product administered at inappropriate site and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Causality Assessment for the events Pain during injection, Injection site redness, Injection site swelling, per Company (Amgen): related. Causality Assessment for the event Product administered at inappropriate site, per Company (Amgen): Not related. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (12Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 12/APR/2021 AND 20/APR/2021: This case was upgraded to serious case. In this follow up, it was reported that the patient had a flare for the past couple of days/pretty bad flare [PT: rheumatoid arthritis], some burning during the injection [PT: injection site pain] while receiving Enbrel, Single Dose Prefilled Autoinjector. It was previously reported that the patient first injected close to her knee and had a bad injection experience with immediate pain and swelling at the site. On unknown date in APR/2021, the patient stated that for the past couple of days she had a flare especially in her hands. On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain. On 16/APR/2021 (Friday of last week), the patient had a pretty bad flare that subsided on the weekend prior to her last injection. On 19/APR/2021, the patient injected in her thigh and she had some burning during the injection that lasted for about a minute afterwards. The outcome of the events rheumatoid arthritis and injection site pain were reported as recovered/resolved. The event injection site pain was resolved on 19/APR/2021. The event rheumatoid arthritis was resolved on an unknown date in APR/2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis, Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen Comment: This individual report does not change the safety profile of the product. Amgen Causality Assessment: Rheumatoid arthritis flare up, Product administered at inappropriate site assesses as unrelated while Injection site redness, Injection site swelling, Pain during injection assessed as related to etanercept. Follow-up (26Apr2021): The following clarification was received from Amgen to clarify the route of administration of Enbrel, included: The event reported was Product administered at inappropriate site "gave it down towards her knee on her leg [PT: product administered at inappropriate site" & "when she injected the area swelled up as she gave it and became red." Following the initial dose that was administered inappropriately, "On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain" The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Follow-up (27Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 27/APR/2021: The outcome of the previously reported event rheumatoid arthritis was updated to recovering/resolving. Action taken with Enbrel, Single Dose Prefilled Autoinjector for the previously reported event rheumatoid arthritis was updated to not applicable. In this follow up it was reported that the patient experienced a flare/ feeling really bad [PT: rheumatoid arthritis] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medication included COVID-19 (corona virus disease-2019) vaccine. On 25/APR/2021, Sunday, the patient received her second dose of COVID (corona virus disease) vaccine. So, the patient skipped a dose of Enbrel therapy. Then on 26/APR/2021, yesterday of this report, the patient felt really bad. She thought the vaccine put her into a flare. She was doing a little better today. She would restart Enbrel later today and switched her injection day to Tuesday. She also mentioned that this time, she didn't have a flare at the end of the week, as she had with her prior dose. So, she thought that without the COVID vaccine, she would had been fine. The outcome of the event rheumatoid arthritis was reported as recovering/resolving. No follow-up attempts are possible. No further information is expected. Amgen comment: This individual report does not change the safety profile of the product. The reporter's assessment of the causal relationship of the events with the suspect products etanercept and BNT162B2 (reported as "COVID vaccine") was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen's Causality Assessment: The events Pain during injection, Injection site redness, Injection site swelling were related to etanercept. The events Rheumatoid arthritis flare up, Product administered at inappropriate site were unrelated to etanercept.; Sender's Comments: The reported events of injection site pain, injection site swelling and injection site erythema were assessed as possibly related to etanercept based on temporal association and known drug safety profile. Reported event rheumatoid arthritis flare is an intercurrent medical conditions and is unlikely related to Enbrel. Pfizer comment: Confirmed the Amgen assessment for Enbrel. The reported events were assessed as not related to BNT162B2. The events preceded, most of them already recovered, at the time of vaccine injection.

From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).

Vomited suddenly without knowledge of being nauseous; only happened once but nausea remained after. After about an hour and a half muscle aches and headache kicked in.

Fever, muscle pain. Onset around 21 hours after vaccine, resolved around 6 hours later without intervention.

Really strong left arm pain around injection site. Not able to extend or retract my arm for the day after injection. Was really painful, couldn't sleep or apply pressure to arm, also at one point I had an extremely sharp/shooting pain that was in my left arm/neck. Currently 5 months pregnant, due June 7th 2021

Around 12 hours post-vaccination with the 2nd dose, noticed severe chills, fatigue, headache, and full-body myalgias. Severe chills lasted ~6 hours, then subsided. Severe fatigue continued for ~24 hours (still feeling fatigued, but it is improving). Milder chills continued for ~24 hours but have mostly subsided. Headache and myalgias have improved over the last 24 hours but are still present despite use of ibuprofen 200mg Q6H.

I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230. At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.

swollen lymph node in her left axilla/lymphadenopathy; pain in her left axilla; able to palpate a swollen lymph node in her left axilla; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685), intramuscularly in the left arm on 17Dec2020 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. There was no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine and fexofenadine hydrochloride (ALLEGRA), both for unknown indications from unknown dates and unknown if ongoing. The patient previously took and had an allergy to amoxicillin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 13:00, the patient developed pain in her left axilla (6 days after vaccination). The patient was able to palpate a swollen lymph node in her left axilla. It continued to become more painful requiring ibuprofen and hot compresses. By 31Dec2020, her symptoms had largely resolved. She saw her physician who also felt the lymphadenopathy and had no other explanation than possible vaccine side effect. The clinical outcome of pain in her left axilla, swollen lymph node in her left axilla/lymphadenopathy, able to palpate a swollen lymph node in her left axilla was recovered on 31Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.

Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling crummy" - fatigue and "really bad" headache. She went home after work and went to sleep. 12/29 onset of feeling "hot" but her temperature is normal. Body aches, slight headache, and feeling "clammy". She took ibuprofen on 12/29 and is currently at work. Employee reports she usually feels mildly ill the day after a flu vaccine but this adverse reaction is much worse than that. 12/30 - employee reports she developed diarrhea and a temp to 99. Continues to have body aches and mild headache. 12/31 all symptoms resolved.

Approximately 4 hours after the vaccine administration, I started getting symptoms that started mild and became severe including: headache, dry cough with chest pressure, dizziness/lightheaded, joint pain, body aches, fatigue, and chills. At 5:30 pm I started getting a fever, that started at 100.5 then increased to 103.3 by 8:30 pm. I was also nauseous and vomited once. I was tested the next morning for influenza and COVID and was negative. My fever came back down to 98.8 around 12 pm the next day. Overall, symptoms lasted approximately 30 hours after the vaccine was administered. I was out of work the following day after the vaccine. Now, 2 days after the vaccine I am just mildly fatigued with a dry cough left.

Swollen Lymph Node in left armpit/general left armpit swelling with pain (approx. circumference of a baseball). Began 4-5 days post first vaccination dose and has grown in size and worsened in pain. Makes movement of arm uncomfortable and occasionally painful. At the time of writing this report, it has been 1 week since the first dose and the adverse event persists without signs of alleviation.

Soreness in the site of injection on the day of vaccination. Muscle aches, headache and fever began 12 hours after injection. Fever spiked up to 104.1F 16 hours after vaccination. Took Tylenol at hour 16 to help bring fever down. Temperature now 100F and it has been 18 hours since vaccination.

- Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myalgias and arthralgias, fatigue - 24 hours max temp 99.9, chills, sweats - Symptoms all resolved by 36 hours after vaccine

1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Fever resolved. Fatigue and muscle aches still noted

Both at time of first vaccine (12/19) and second vaccine (1/5) I had the same symptoms: headache, muscle and joint aches, malaise, fatigue, and pain at injection site

Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30 minute period onset of fever, myalgias, chills, and nausea. Called off work from my job as a flight nurse at midnight. Tried to sleep it off until about 0430 when the body aches became unbearable. Ate a few bites of yogurt and took 400mg of ibuprofen. No change in symptoms until 0530 when I took a hot shower which helped relieve some muscle pain. Took 400mg ibuprofen again at 1030 with a small snack with no change in pain or fevers. Took hot shower again which helped briefly. Nausea subsided around 1630, enough that I had a small meal of bland food and another 400mg of ibuprofen. By 1700 more tolerable myalgias and fever came down some. 2230 another 400mg dose of ibuprofen, fitful night of sleep waking again at 4am with shooting lower back pain and fever. Took another dose of 400mg ibuprofen and a hot shower. Woke up at 1000am sweaty with mild myalgias and low grade fever. Took another dose of ibuprofen 400mg, 30 minutes later profusely sweaty but afebrile. Fatigued all day and poor appetite until late evening. Woke up next day after better night of sleep at 0730. Mild fatigue and bad heartburn all day and night. Left arm still sore to touch. This morning (1/11) feeling mild heartburn but better.

Approximately 10 minutes after receiving the vaccine she started experiencing numbness and inability to move all 4 extremities. No difficulty breathing or swallowing. Benedryl 25 mg was administered with no relief. EMS was called, she was transported to the ED and admitted to the hospital for evaluation. She was given Ativan 0.5 mg IV with some mild improvement in symptoms. She has had gradual improvement in her symptoms, now able to move her arms normally. She has persistent weakness and discomfort in both lower extremities and is unable to ambulate without assistance.

Fever, chills, headache, myalgias started around 10 pm worsened through the night. Fatigue the next day and nausea. Headache has persisted still have it currently. Have been hydrating and taking ibuprofen which helps

myalgias; Headache; nausea; chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, intramuscularly on 17Dec2020 at 10:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) from an unspecified date, for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020 at 16:30, the patient experienced headache, nausea, chills, myalgias. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the headache, nausea, chills, myalgias was resolved on an unspecified date in 2020. No follow-up attempts are possible. No further information is expected.

About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grade fever of 99.9, chills, headache, nausea and fatigue that persisted until Friday evening. Saturday I experienced a headache and nausea, loss of appetite and whole body fatigue and soreness in back, neck and arm. Headache, fatigue, loss of appetite and nausea persists till now (Monday/Day 4)

Fever with temperature of 102.4F; Chills; Body aches; sore joints; Vomiting; The patient received the second dose 19 days from the first dose; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine), first dose intramuscular right arm on 17Dec2020 17:30 [05:30 PM](Ej1685; expiration date: unknown) at a single dose and second dose intramuscular right arm on 05Jan2021 17:30 [05:30 PM] (lot number: EK9231; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history was not reported. Concomitant medication included birth control medication. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient experienced fever with temperature of 102.4F, chills, body aches, sore joints and vomiting on 06Jan2021 01:00. The patient received the second dose on 05Jan2021 17:30 which was 19 days from the first dose. The patient did not received treatment for the adverse event. The patient has not tested for COVID-19 since the vaccination. The reporter assessed the events as non-serious. The outcome of the events was not recovered.

Muscle fatigue; Chills; Headache; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at a single dose then intramuscularly (left arm) on 05Jan2021 18:30 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 19:00, the patient experienced Muscle fatigue, chills, headache and fatigue. No treatment was provided in response to the events. The patient assessed the events as non-serious. The patient underwent COVID test post vaccination via nasal swab (PCR) on 21Dec2020 and was negative. The outcome of the events was recovering. No follow-up attempts are possible, information about lot/batch cannot be obtained.

Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of "tested positive for COVID after receiving the COVID Vaccine" was unknown.

Same day extreme lethargy, woke up with severe muscle and joints pain, specifically my hips, general body weakness, headache, low grade fever 99.4 and taking Tylenol 01/9 still feel lethargic and 1/10 intermittent cough and heaviness when I breathe

dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and broke out in rash around injection site; pain and stinging on injection site location; heat and redness as well as a raised rash; heat and redness as well as a raised rash; Both ears got, rot and itchy, stomach itchy; Both ears got, rot and itchy, stomach itchy; fever of 100.7; sever heart burn; severe body aches; head ache; raised rash; This is a spontaneous report from a contactable other Health Care Professional (HCP) who is the patient. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown, expiration date unknown) via an unspecified route of administration on 04Jan2021 at 10:00 AM (at the age of 28-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included removal of a metastatic carcinoid tumor from an unknown date and unknown if ongoing. The patient's allergies include minor hive breakouts from "several things." The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 17-DEC-2020 at 14:00 (at the age of 27-years-old) at an unspecified dose in the right arm. The patient was not pregnant at the time of this vaccination. The patient was administered the vaccine in the hospital. Prior to this vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included drospirenone;ethinylestradiol;levomefolic acid (reported as "generic form of Beyaz") and acetaminophen.The patient did not receive any other vaccines within four weeks prior to the first vaccination. On 04Jan2021 at 10:00 PM the patient experienced severe body aches and head ache, through out that night. She had dizziness and nausea with increased joint pain and body aches with the head ache increasing as well. On the morning of 05Jan2021 she experienced a fever of 100.7 and body aches. On that same day in the afternoon these symptoms subsided. She also experienced severe heart burn on 05Jan2021 that did not subside with Tums. On Wednesday 06Jan2021 she was feeling much better, and she had a "normal day." At 12:00 AM on 07Jan2021 the patient started itching and broke out in a rash around the vaccination site, and pain and stinging at injection site. She also had heat and redness as well as a raised rash. Both ears got, hot and itchy, her stomach was itchy but not red or swollen, same for the right leg and foot. She took one allergy pill, and twenty minutes later was still having a bad reaction so she took another allergy pill. She stayed awake to fill out this form, and she was hoping the reaction would stop spreading. Treatment was reported as having taken Tums for the severe heart burn and the patient also took an unspecified "allergy pill" for the itching, vaccination site rash, pain and stinging, the heat, redness and raised rash, the red, hot itchy ears, and the itchy stomach. The clinical outcome of the events severe body aches and fever was reported as recovered on 05Jan2020. The clinical outcome of headache, dizziness, nausea, joint pain, heartburn, vaccination site rash, vaccination site pruritus, vaccination site pain, feeling hot, redness, itchy, ear disorder and raised rash was reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Headache; Unexplainable crying/emotional; Unexplainable crying/emotional; Awful R shoulder pain; This is a spontaneous report from a contactable other HCP (patient). A 28-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231), via an unspecified route of administration on 05Jan2021 at 12:45 at single dose in right arm for covid-19 immunization. Medical history included acute lymphoblastic leukemia at age 11, remission for 14 years. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced allergies. The patient experienced headache, unexplainable crying/emotional, awful right shoulder pain; all on 05Jan2021 at 15:30. All events were reported as non-serious. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.

My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles were achy, felt weak, my neck was sore and I had a knot at the injection site. I took 400 mg of ibuprofen around 7am on 1/12 and my symptoms subsided until around 3pm and started getting chills and leg aches. My arm developed redness right where the knot is on my arm and I still have the knot today (1/13). I have had no other symptoms since 3pm 1/12.

Fever - began around 0500 the day after my second injection Severe fatigue - began 2 hours after my injection Muscle aches - began around 0500 Rigors - began around 1200 Treated with ibuprofen and sleep Symptoms resolved by the morning of 1/13 at 0700

I received the first dose of the Pfizer vaccine on December 23 with no complications. The second dose of Pfizer was administered to me on January 11 and I felt okay at first. At 1 am on January 12 I developed severe chills and muscle aches. The chills, body aches, and fatigue persisted all day. Temperature max was 100.3 orally. I continued to take Tylenol every 6 hours and stayed in bed. The next day I felt slightly better, however, still had a headache. I made an appointment with my primary care doctor.

Fever as high as 101.5F and chills starting since 1am, lasting until 10pm. Extreme body and muscle aches. headache that was not alleviated with tylenol or advil.

joint pain; Chills; body aches; This is a spontaneous report from a contactable other hcp. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EK5730, intramuscular in the right arm, from 06Jan2021 16:15 to 06Jan2021 16:15 at a single dose for covid-19 immunization. The patient medical history was not reported. Historical vaccine included BNT162B2 on 17Dec2020. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced joint pain, chills and body aches. The outcome of events was recovering. No treatment was received due to events. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.

Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pain); Mild back pain on injection side; This is a spontaneous report from a contactable Nurse (the patient). A 28-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246, expiration date unknown) via an unspecified route of administration on 05Jan2021 at 08:45 (at the age of 28 years old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date, allergy to Penicillin and seasonal allergy from unknown dates.The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. Prior to the vaccination, the patient was diagnosed with COVID-19 (date not specified) The patient's historical vaccines include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK5730, expiration date unknown) on 15Dec2020 at 3:00 PM (at the age of 28 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient was tested for COVID-19 after the first vaccination in the form of a nasal swab test on 24Dec2020 which was negative. Concomitant medication included cetirizine hydrochloride (ZYRTEC), biotin (BIOTIN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports having experienced a headache five (5) hours post the second vaccine, soreness at injection site, fatigue and muscle aches eight (8) hours post the second vaccine, chills and dizziness twelve (12) hours post the second vaccine, and TMJ aching and mild back pain on injection side twenty-four to forty-eight (24-48) hours post the second vaccine. Treatment was received for the events and included acetaminophen and ibuprofen.The clinical outcome of the events headache, vaccination site soreness, fatigue, muscle aches, chills, dizziness, joint aching and back pain was reported as recovered on an unspecified date in Jan2021. It is unknown if the patient has been tested for COVID-19 since the second vaccination.

About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly burning sharp pain, but some restricting tight pain as well, radiating to my back mostly. It would be relieved for maybe 10 minutes at a time but then flare back up for about 5 hours. I went to the emergency room, where they did a cardiac work up including blood work and EKG, vitals and a chest X-ray, all which were unremarkable. At about 0200 am on 01/13, the pain subsided. Previous to the chest pain, during the morning and afternoon of 01/12, I had a low grade fever (99.9 F), an intense headache, and fatigue. 01/14/21 sore swollen lymph node under L arm.

same day: pain at injection site next day: headache, fatigue, paint at injection site, muscle aches 2 days after: no symptoms

Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin tingling, joint pains, muscle aches

Nausea, lightheaded, elevated BP. Went home and started having body aches, joint pain. Improved nausea.

The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen lymph nodes in the pectoral area (as all other testing at the ER was normal). Also sharp pain when breathing in deeply.

swelling x 3 days and pain/tenderness of the L axilla with no palpable lymphadenopathy x 6 days. No treatments given. Outcome: continue to have mild tenderness, swelling has decreased.

Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.

I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violent and coarse rigors, severe enough to contract the spine into hyperextension if I kept my body in a neutral position. I could still activate each muscle group to keep in a fetal prostration pose. I was knowledgeable of the event, did not loose any bowel, bladder, or smooth muscle function, and the intensity of the rigors was focused on the most developed skeletal muscles (thighs, calves, upper arms, forearms, paraspinal muscles, hands, respectively). Jaw and muscles of the head/face seemed unaffected. Fingers and toes not distinctly affected. I was not sweating at this time and there were NO other symptoms to report; I remained lucid and able to self-reflect the entire time. Home temperature is kept to consistent 66F, no malfunctions to thermostat. No recent changes to bedding (sheet and quit on top of mattress); it is even optimized for me as I tend to overheat as I sleep. At 50 minutes, I felt "less frozen" and confident enough to stand/ambulate for 220mg naproxen + 500mg APAP , cautiously and successfully swallowed. Robe was donned over existing pajamas and thick comforter was pulled from hallway closet. Rigors continued, but it appeared that intentional activation of the muscle groups could still overpower the rigors for safe (but shaky) ambulation. Greatest risk was coarsely shaking hands a bringing cup to mouth to swallow pills. Above activity was completed in 5 minutes. I then sat upright in bed under layers above. I could feel the muscles calm and relax, with episode completely ending in 5 minutes. Total time of event: 60 minutes. Post-event details: There was a mild sensation of muscle tension in the posterior cervical spine akin to whiplash, but no residual symptoms. I debriefed with my husband shortly thereafter (he has been in another room the whole time) and fell asleep by 23:30. Awoke to alarm at 05:00 and able to stretch, accomplish 30 min run, vacuum/mop the floors, and present to work by 08:00am without deficit. Time of documentation: 11:22 am 1/15/2021

Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; Second dose: fever, chills, muscle and joint pain, headache, fatigue; This is a spontaneous report from a contactable other HCP. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 08Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included postural orthostatic tachycardia syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (anatomical Location: Arm Left) on 18Dec2020 09:30 and experienced headache, arm pain. Concomitant medication included spironolactone and metoprolol. The patient experienced events after the second dose: fever, chills, muscle and joint pain, headache, fatigue on 08Jan2021 21:00. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information about lot/batch number has been requested.

The night of receiving the vaccine, I developed chills and myalgia that progressively got worse into the morning. Then I developed a fever of 38.6

24 hours after getting the vaccine, had whole body chills followed by fever to 101.3 F. Had diffuse arthralgias and myalgias. Mild improvement with acetaminophen.

Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, fever, headache, nausea and 1 episode vomiting, myalgia throughout body, dizzy/lightheaded ness and extreme fatigue. The next day Jan 16 had diarrhea all morning

Several hours after receiving the vaccination, I became fatigued and sore with muscle aches in the arm of the vaccine site. That night I woke up with moderate body aches and chills and a dull headache, no fever. The next morning, I awoke feeling very fatigued, severe muscle/body aches, headache and chills, still no fever. I slept most of the day. Extra strength Tylenol helped tremendously with the body aches. I was symptom free the morning of 1/15/2021. I was scheduled to work the day after my vaccination and was unable to due to the symptoms described. I had no adverse reactions with my first dose. I am a nursing mother and for the first and second doses, I noticed no side effects or any concerns with my child or milk supply.

I received the dose at 12:00pm Saturday and by midnight I was awoken with severe 9/10 pain to my left arm radiating up my left side of my kneck to my ear and down to the middle of my back. This follows Sunday morning with muscle aches, joint pain, headache and nausea. Continuous nausea occurs until vomiting starts sunday mid afternoon. This all continues until Tuesday morning when a Phenergan shot IM is able to be administered at urgent care where I return home and sleep for 24 hours. Tiredness and weakness continue until the morning of Saturday 16th where I wake up feeling "normal" in a sense.

Starting 6 hours post vaccine - arm started to feel sore, unable to lift straight up without soreness 8-10 hours after - headache began, treatable with tylenol -- Tylenol dose lapsed Overnight arm increased in soreness, could not sleep because if arm moved it woke me up First thing the next morning - could not lift arm past shoulder, body felt stiff/sore/ very fatigued, headache -- tylenol helped get through the work day -- Extreme fatigue - took a 2 hour nap after work and still had to go to bed by 9p The following day (48 hrs after): dull headache + sore arm but significant improvement - took tylenol to help Arm stopped feeling sore after 72 hrs and no longer had headache.

Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection site)

Muscle aches and headache 12 hours post. Fever and chills 18 hours post that resolved with tylenol. Muscle aches, headache and fatigue 24 hours post.

Arm pain for two days. Fatigue; muscle ache; headache , nausea that day - which lasted three to four days. The day after vaccine - I had a regular scheduled appt with neurologist - she prescribed a new med - Nurtec - I have taken twice since getting the vaccine. I'm still having ongoing fatigue; headache and nausea as well. Got period and it is more heavier than usual - almost went to ER. I have had a lot of pain and cramping associated with it. Have a lot of fluid and tissue coming out now that it's stopped.

Low-grade fever (100.4 F), chills, myalgia, headache. Onset ~8 hours after vaccine administration. Resolved ~48 hours after vaccine administration.

At approximately 9pm the night of the vaccine 2nd dose, I developed a fever. As the night progressed, I also developed severe R arm pain, joint pain, muscle aches in my back, chills, a headache, and fatigue. The fever was as high as 103.1 and improved with tylenol, but lasted for 2 days. Since onset of the back pain, it has persisted and gradually worsened over the past 2 weeks since the injection. I contact my physician, received a prescription for a muscle relaxant, and a referral for physical therapy.

12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOSE (AFTERNOON/EVENING): WORDS/CHALLENGES COMMUNICATING FOR 24 HRS

Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after vaccine given. Patient also noticed stiffness in neck, feeling of pins and needles and some skin burning. Additionally endorses feeling a dry mouth sensation.

Headache, myalgias - present about 12 hours after vaccine was given, resolved after one day without problems. R sided supra clavicular lymph node - tender, enlarged, started 3 days after vaccine, still present

Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5 1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet 1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps 1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen

weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night. She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021. The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in their neck, and dizziness. Care was managed on-site by EMS and patient refused transport to hospital. Signed refusal of EMS transport states non-urgent acuity at time of discharge.

Labored breathing/shortness of breath; Extreme fatigue; Resting heart rate 104 bpm; Full body myalgias; Nausea; This is a spontaneous report from a contactable pharmacist. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the left arm on 09Jan2021 17:00 at a single dose for COVID-19 immunization at a clinic. Medical history was reported as none. Patient has no known allergies. The patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (VELIVET). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at the left arm on 21Dec2020 14:45. The patient experienced full body myalgias, nausea, extreme fatigue, resting heart rate 104 bpm, and labored breathing/shortness of breath on 10Jan2021, 04:30. There was treatment for the adverse events. Patient has not been tested for COVID 19 prior and post vaccination. The patient was recovering from the events.

Headache; Myalgia; Fever; Fatigue; The patient experienced chills overnight; This is a spontaneous report from a contactable pharmacist (patient). A 28-year-old no pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), intramuscular in left arm on 06Jan2021 17:45 at single dose for COVID-19 immunization. None Medical history included. Concomitant medication included sertraline and ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient experienced chills overnight (06Jan2021). On 07Jan2021 02:00 am, she experienced fever, headache, myalgia, and fatigue. Self-treated with Acetaminophen. The outcome of events was recovered at unspecified time on 07Jan2021.

Symptom onset was sudden - rigors, temp 102.3, bilateral cyanosis in hands. Difficult to take Tylenol because jaws became clenched. Symptoms resolved after the administration of Tylenol and ibuprofen. Extreme muscle aches the next two days and mild fever that was controlled with medication.

My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .

sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy than usual unsure if related.

Headache started 20-30 minutes after administration, off and on the last 24 hours. Sore left arm with pain in armpit/lymph node area. Tingling pain down to left elbow and hand. Sore back and shoulder. Chills throughout night sleeping and into next night

Within 24 hours after administration of 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA, patient began experiencing tingling and numbness in hands and feet, weakness, fatigue, muscle and joint pain, chills, fever of 100.4 F, headache, and nausea, in that order developing over the next 48 hours.

Sore arm (and got really red; tender and really swollen) and body aches and muscles aches; slight fever; severe headache and chills -counted get warm - lasted about 48 hours. But my arm was really sore for another 2 days after all the other symptoms cleared. Treated with Tylenol around the clock throughout.

This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date not reported), via an unspecified route of administration in the left deltoid on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis from 2009 and exposure to a positive COVID patient on 08Jan2021. The patient also had a sinus drainage down the back of her throat. It went away but started back up on 09Jan2021. It is the same since last night but had improved from over the weekend. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) on 21Dec2020 at single dose for COVID-19 immunisation. The patient had her second COVID19 Vaccine dose last Saturday and reported having a "weird reaction". She had already gone to urgent care and was told to call. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist), which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Patient said that she was not sure if she was having a reaction or not to the Pfizer COVID Vaccine. She was just in urgent care that morning and was going to primary care that afternoon. Urgent care thought she was having a reaction. She got her second dose of the vaccine on Saturday morning, 09Jan2021. That night she had the typical immune response. She had chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure, which lasted through Sunday. She took Sudafed PE and Monday when she woke up, she felt normal. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist, fingers, feet, face, upper arms), rash which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Benadryl helped it get better, but after it wears off the rash comes back and it gets worse. It had spread to different areas. Sometimes, it will be really bad on her knees, then other times really bad on her elbows or hips. Her hips were bad last night. Now it is on the bottom of her feet and on her knees again. She asked if these were something that have been previously reported. All of these symptoms, besides the rash, she felt like she had the flu. It knocked her on her ass it was pretty terrible. But it went away and she felt better. It was a typical immune response so she would say it was not serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. Clinical outcome of events chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure was recovered on 11Jan2021, while for the other events was not recovered.

Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a contactable healthcare professional who reported for herself. A 28-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3248) via an unspecified route of administration 13:15 on 14Jan2021, at left arm, for Covid-19 immunization. The patient received first dose at left arm 03:15 PM on 22Dec2020. The patient's medical history included vertigo. The patient had no known allergies and no Covid-19 prior to vaccination. Concomitant medications included meclozine, montelukast, mometasone furoate (NASONEX), atomoxetine hydrochloride (STRATTERA), and levocetirizine dihydrochloride (XYZAL). 02:00 AM on 15Jan2021, the patient developed fever (100.5), abdominal pain, aches, muscle aches, chills. No treatment was received. The patient had not tested for Covid-19 after immunization. Outcome of the events was not resolved at the time of reporting. The reporter considered that the events were non-serious.

high fever 102.6, severe body aches, chills,sweats, headache, neck pain,weakness, fatigue, nausea, runny nose, 48 hrs and going

Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye pain when looking at light

Had a low fever of 99.9 throughout the day, chills, severe headache, joint pain and weakness, dizziness, nausea.

10:30am- 2nd dose received 1:30pm -fatigued/ headache (Advil taken, symptoms subside) 6pm - fatigue/ sore arm/ headache (Tylenol, symptoms worsen) 11:30pm- chills, body/ muscle aches, clammy 1:30pm- worsening chills, worsening aches, insomnia, restless legs, panic attack 5am- nausea, aches, chills, fever (Tylenol & Zofran- helped minimally) continued lack of appetite Symptoms subside Approx 48 hrs after 2nd dose.

Malaise, body/joint aches, lymphadenopathy of the left axilla and bilateral cervical lymph nodes (level 1 a/b), mild headache. Onset one day after injection. All symptoms resolved by the next day, with exception of the axillary lymphadenopathy.

Chills, joint pain, chest pain, shortness of breath, low grade fever, nausea, vomiting, headache. Recovered from COVID in 8/2020.

On 12/30 I developed neck pain, a headache, chill and shaking but no fever, diarrhea, ear pain and nasal congestion. I had a virtual visit with the NP and was advised if the symptoms got worse to take tylenol and ibprophen. I was advised I could take mucinex and recommended a COVID test. It was performed on 12/31 which was negative so I took mucinex for the congestion and after 2 or 3 days I began to feel better.

Headache, chills, shivering, body aches, joint pain, lethargy started 12 hours after 2nd dose. Lasted about 18 hours. Headache lasted 3 days

post covid vaccine symptoms included, fatigue, lightheadedness, cold sweats, brain fog, severe neck and back aches.

fatigue; dizziness; nausea; muscle soreness; This is a spontaneous report from a contactable consumer. This 28-year-old female consumer (patient, pregnant: No) received 1st dose of BNT162B2 (COVID vaccine) on 15Jan2021 06:15 PM at single dose on Left arm for covid-19 immunization. Medical history was Herniated disc. Known allergies: Steroids and anti-itch creams (unspecific). No other vaccine in four weeks. Concomitant drug was ethinylestradiol/norgestimate (SPRINTEC), Omeprazole. Patient reported experiencing Fatigue, Dizziness, Nausea and muscle soreness for 3 days since receiving the vaccine on 15Jan2021 08:00 PM with outcome was not recovered. No treatment. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/batch number has been requested.

Headache; neck pain; shoulder pain; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21Jan2021, at 10:30 as first single for covid-19 immunization. Medical history included tonsillectomy, appendicectomy and gastric bypass on unknown dates and unknown if ongoing. No allergies to medications, food, or other products were noted. The patient received unspecified bariatric multivitamin within two weeks of vaccination; the patient did not receive any other vaccines within four weeks prior to the vaccine. On 22Jan2021, at 09:00 patient experienced headache, neck pain and shoulder pain. The events were assessed as non-serious. No therapeutic measures were taken as results of the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The outcome of headache, neck pain and shoulder pain was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .

Hives; itching; shortness of breath; chest tightness; severe hip and low back pain; severe hip and low back pain; headache; concomitant medications included mercaptopurine; concomitant medications included mercaptopurine; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular at right arm on 19Jan2021 at 15:00 at single dose for COVID-19 immunization. The patient medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient's concomitant medications included mercaptopurine, mirtazapine (REMERON), sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC). The patient previously took ADDERALL, HUMIRA and REMICADE and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at right arm on 30Dec2020 at 15:45 at single dose for COVID-19 immunization. On 20Jan2021 at 06:00, the patient experienced hives, itching, shortness of breath, chest tightness, severe hip and low back pain and headache. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine, EPI PEN, TORADOL, acetaminophen, DECADRON, DILAUDID. The patient outcome of the events was resolved with sequel.

Body aching, fatigue, and mild stomach ache lasting about 24 hours. Low back pain lasting about 48 hours.

Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her body, all muscles felt heavy and weak; could not control her body, all muscles felt heavy and weak; Felt tingles in feet and lower legs; This is a spontaneous report from a contactable consumer(patient). The 28-year-old female patient(not pregnant) received first dose BNT162B2(COVID 19, lot number: EL9262), via an unspecified route of administration at left arm on 22Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included none. She had no known allergies. Concomitant medication included spironolactone, amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin b complex (VITAMIN B), ergocalciferol (VIT D), ZINC, omeg(omeprazole). There was no other vaccine in four weeks. About 11 hours after receiving(23Jan2021), she very quickly became disoriented and weak, could not control her body, all muscles felt heavy and weak. She fell once and then presumably passed out - she came to after falling again. She felt tingles in feet and lower legs. After sleeping about 9 hours, she felt better. There was no treatment received, no covid prior vaccination, covid tested post vaccination. Events were assessed as non-serious. Outcome of events was recovering.

Fever up to 102, headache, body aches and pains, muscle soreness and stiffness, joint pain, tiredness but not able to sleep.

I found out I was pregnant the day after receiving the first dose of the COVID-19 vaccine. My last period was on December 8th and I received the vaccine on Dec 30th. I developed a fever and muscle aches after the first dose, but was managed with Tylenol. I received the second dose on January 22nd and again developed a fever that was managed by Tylenol. I began having vaginal bleeding on 24th. I had an ultrasound revealing a heartbeat on the 25th. After continually bleeding, another ultrasound a week later on Feb. 2nd confirmed a miscarriage. I've had two healthy pregnancies prior to this one.

Lightheadedness within 5 minutes; weakness of muscles; rapid heart rate; This is a spontaneous report from a contactable other HCP reporting for herself. A 28-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , intramuscular on 25Jan2021 09:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medicatons were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced lightheadedness, weakness of muscles and rapid heart rate on 25Jan2021 09:15 with outcome of recovering. The patient was treated in Emergency Room with steroids and anxiety medications. Information on the lot/batch number has been requested.

Headache 5am, hurts to lift head or move neck; Nauseous since 1am; Chills since 1am; All over muscle aches and pains 530 am; Fever 100.4/feeling feverish 6am; Shaking/shivering since 3am

stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested.

tingling and numbness in hands and feet; tingling and numbness in hands and feet; weakness; fatigue; muscle and joint pain; muscle and joint pain; chills; fever of 100.4 F; headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 26Jan2021 18:00 at a single dose on the left arm for COVID-19 immunization. Medical history included asthma, fibromyalgia, ADHD, GERD, IBS, and allergies to pollen and yellow onions. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), diltiazem, and topiramate. Patient is not pregnant at the time of vaccination. The patient received the first dose of bnt162b2 on 05Jan2021 15:00 (lot number: EL1284) on the left arm. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 post-vaccination: Tempus iC SARS-CoV-2 RT-PCR on 28Jan2021 with result negative. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 14:00, within 24 hours after administration of second dose, patient began experiencing tingling and numbness in hands and feet, weakness, fatigue, muscle and joint pain, chills, fever of 100.4 F, headache, and nausea, in that order developing over the next 48 hours. Patient has not recovered from the events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes Tylenol. Events reported as non-serious.

Fever (99.7 degrees F), chills, muscle aches, joint aches, severe dizziness, significant fatigue, severe migraine. All symptoms started at 4:00 am 2/13 and were present throughout the entire day 2/13. Migraine and dizziness persisted until 2/15 but lessened in intensity each day. managed symptoms with Aleve

Pfizer-BioNTech COVID-19 Vaccine EUA injected into left arm at 10:15 am on 17 Feb. Soreness at the injection site was the only symptom immediately following the injection. At about 3:00 am the next morning, I experienced extreme nausea and chills. I fainted when I tried to get out of bed to go to the restroom. All of 18 Feb, I experienced the following symptoms: headache/migraine, fatigue, dizziness, loss of appetite, muscle aches/soreness, fever, and severe pain in my left arm. As of today, 19 Feb, I am experiencing headache, lightheadedness, and mild pain my left arm.

Pain began as a "crick" in the left side of the neck two days after receipt of second covid vaccine. It has now been three weeks and pain has been continuous in the left shoulder and left neck. Pain radiates down the arm and up into the ear, making the ear hurt and making it painful to swallow. The skin is also tender/painful to touch in the same areas, as if nerve damage has occurred. Swelling is visible in the upper back and neck.

Walking around house doing chores after working from 9-6 with 90 minute lunch break as a dental hygienist. Could feel left foot start to go numb and tingling and feel very cold. Took thin sock off foot, pinky toe was purple. Took pictures. Could not get foot to warm up with warm/hot compresses. Started having slight discomfort in lower back/butt with pain going down leg to toe within the hour. I believe this could be coincidence and have sciatic pain, but thought I should report just in case there are few other reported cases on this. Purple discoloration was gone when woke in morning on 2/23/2021 It is now 2/24/2021 and I am still having sciatic pain and numb pinky toe.

Little shortness of breath; Dizzy; very tired; Chills; Stiff neck/ head and neck are very stiff; Felt crummy; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 21Jan2021 at a single dose on the left arm to be prevented from COVID 19. The patient's medical history included COVID from 04Dec2020 and after that, on unspecified date, COVID test was negative. Concomitant medication was reported as none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on the right arm at 28- years of age to be prevented from COVID 19. On 21Jan2021, the patient had what everyone was talking about, the chills and stiff neck, she felt crummy, muscle aches, thought it was the normal. The next day (22Jan2021), she had a little shortness of breath, she felt dizzy on and off and her head and neck are very stiff, and she is very tired. The outcome of the events stiff neck/ head and neck are very stiff, felt crummy, and dizzy was not recovered while the other events was unknown. Information about lot/batch number has been requested.

Painful arm (could not lift arm) for 2 days Cough Fever Body aches/chills Loss of smell/taste Dizziness Headache Extreme fatigue Neck pain These symptoms lasted approximately 9 days

1/15/21 Chills a few hours later after vaccine 1/16/21 temp 99.9 despite Tylenol, nausea, shoulder, chest pain, cold sore call out sick on 1/16 and 1/17

Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes left armpit; tingling left wrist; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el9261) via an unspecified route of administration on the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included drospirenone, ethinylestradiol (NIKKI) for birth control. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (lot number: ej1685, left arm, 02:00 PM). On 26Jan2021 04:00 AM, the patient experienced fever, chills, Muscle aches, swollen painful lymph nodes left armpit, tingling left wrist, headache, fatigue. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Post vaccination, the patient has been tested for COVID-19, nasal swab on 25Jan2021: pending result. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. Outcome of the events was not recovered.

Four hours after receiving my COVID vaccine second dose I had a headache. The next morning I developed a fever up to 100.8 F. I was very nauseous and fatigued. I was unable to work because of my fever. The fever lasted two days. The headache lasted five days. The nausea continued and I found out I was pregnant that Friday. I have had severe morning sickness I?m on three medications to try to help keep it at bay. I?ve lost 13lbs. But the baby is looking healthy. I am due in September.

Extreme armpit pain/breast pain on side of the injection that lasted 3 days. Lymph nodes were able to be palpated and a bit swollen.

28-year-old female, medical assistant employee presents to urgent care 45 minutes after receiving her second dose of covered vaccine, presents to urgent care complaining of a 4 of 10 throbbing headache and left ear/lateral neck pain. She has not taken anything for pain, having come straight from work/vaccination clinic. She tolerated her first dose of vaccine well.

Significant swelling in left axillary lymph node; fever up to 102.7 F/low grade temp in low-mid 100s; Severe chills; fatigue; Moderate muscle aches; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital, via an unspecified route of administration on 28Jan2021 at 15:00 on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to penicillin and sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol, norgestimate (ESTARYLLA) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 06Jan2021 at 12:00 PM on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced fever up to 102.7 F lasting from 05:00 on 29Jan2021 to 01:00 on 30Jan2021. The patient took 3 doses of 1000 mg Tylenol during this time period which would bring temp down to high 100s for an hour or two. After 01:00 on 30Jan2021, the patient had low grade temp in low-mid 100s until the afternoon. The patient also experienced severe chills, fatigue, moderate muscle aches on 29Jan2021 at 05:00. The patient had significant swelling in left axillary lymph node starting on the evening of 30Jan2021. The patient received treatment for the event fever but did not receive treatment for the other events. The outcome of the events was recovering. The events were reported as non-serious.

back of her left shoulder is very painful; soreness; weakness in left arm; horrible pain injection site; redness at the injection site for 3 days after; Stomach pain; Nausea; Headache; redness in left arm; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, intramuscularly on 25Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy diagnosed a couple of years ago, ongoing food allergy she has had allergies to tree nuts, peanuts, shellfish, and sesame seeds her whole life. Concomitant medications include an unspecified product. The patient previously received the first dose of BNT162B2 on 04Jan2021 at around 12:30-13:00, intramuscular injection in left arm Lot number: EL1284 for COVID-19 immunization and experienced soreness. The patient also reported to have received a flu shot on an unspecified date in 2019 and had soreness. The patient reported to have received the second dose Monday, 25Jan2021 at 14:00 and had redness in her arm which recovered completely on Thursday 28Jan2021. On Tuesday night, 26Jan2021, the patient was sick with stomach pain, nausea, and a bad headache that went away by Wednesday, 27Jan2021. She was less sore on Wednesday, 27Jan2021, and she worked out, she did yoga, she got horrible pain at the injection site which started on 28Jan2021, Thursday morning in the middle of the night and stopped by the end of the day. States it went away with pain medication. The pain is nothing like she experienced before. The vaccine site area has been a little sore. She did yoga again last night and the same thing happened, she got pain at the injection site that was horrible. Reports the back of her left shoulder is very painful, it is sharp pains that do not go away on unspecified date. Took some Tylenol for pain at the injection site and left shoulder, that didn't help, took Aleve, heat and ice and by the end of the day, patient was fine. Just some soreness until middle of the night again, same reaction as before. Reports she had redness at the injection site 3 days after on 28Jan2021. She forgot to mention that she had weakness in her left arm that started 28Jan2021 and then she was fine and the weakness started again today. The outcome of the events redness in her arm was recovered on 28Jan2021, sick with stomach pain, nausea, and a bad headache was recovered on 27Jan2021, pain at the injection site, back of her left shoulder is very painful, weakness in her left arm was not recovered, while for the rest of the events was unknown. The patient was vaccinated in a hospital.

Patient went to discharge and on standing, felt lightheaded with leg & hand weakness. She complained of chills and nausea and a sensation beginning from her upper arms/shoulders and spreading through to her torso and upper legs. It lasted about 5-10 seconds. She sat down immediately. She was always alert and coherent. Skin was warm and dry. Vital signs: BP = 120/80, P=60, T=98.6, R=18 and regular. She stated she had not eaten breakfast and had only had a cup of coffee all morning. Her symptoms lasted a few minutes. She was given lunch to eat and felt better immediately. It was recommended she contact her doctor/clinic and she said she would do that. She returned to her classroom at 12:15 pm. Follow-up call today (3/4/21) - she stated she had no more symptoms and was feeling well overall.

Fever, muscle aches, chills, sweats, nausea, vomiting, fatigue, tight chest, cough, soreness in shoulder (where I got vaccinated). Nausea lasted about 4 hours, fever lasted about 6-7 hours, aches and sweats lasted about 15 hours, fatigue lasted about 40 hours, chest tightness and mild cough lasted 48 hours and sore shoulder is continuing beyond 48 hours but slowly improving with time

"the next day [after vaccination] the injection site was extremely sore and the pain went up to my neck and down into my hand. From what I heard this is pretty normal so I had no concerns. Over the next couple days the injection site pain was gone along with the neck pain but the wrist/hand pain persisted. It?s now been a week since the pain started and my wrist/hand/forearm are still really sore/achy. I?ve been icing it multiple times a day but the pain persists. It?s especially bad when typing or doing any repetitive motions with my hand. "

18-40 hours after getting vaccine: sensitivity to light headache with light activity (walking more than 5 minutes) fatigue muscle/joint pain injection site swelling and redness soreness at injection site (lasting 48 hours +)

Muscle aches (back); Injection site pain; Headache; Flushing in face; Brain fog; This is a spontaneous report from a contactable other hcp (reporting for herself) A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration single dose on 06Feb2021 10:15 (at the age of 28) left arm for covid-19 immunisation. The first dose (lot# EL12849) was taken on 15Jan2021 10:15 am, left arm. The patient medical history was not reported. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced muscle aches on 06Feb2021 19:00, injection site pain on 06Feb2021 19:00, headache on 06Feb2021 19:00, flushing in face on 06Feb2021 19:00, brain fog on 06Feb2021 19:00. No treatment received. The events outcome was not recovered.

Client stated that she had prior history of vaso-vagal response to vaccinations, finger pricks and blood draws, that usually they have her lay down when she gets shots. She also has had nausea and dizziness after other shots. She felt nauseous within 2 minutes and was pale and faint, weak. Checked her bp was between 100/60 and 120/80 pulses 40-60. she was"passing out" between answering questions, called EMS and asked her about what she had eaten this morning. she stated some of a bagel but not all. F/U on 3/12 states she felt better with normal BP/pulse while in ambulance and the EMS released her with out transfer, she sat in her vehicle for 1 hour before driving home. she felt weak with sore shoulder on 3/11

Large red raised area at injection site, warm to the touch. Fever of 99.8, muscle and body aches, fatigue, migraine, un-productive coughing, chest tightness, difficulty breathing.

First dose: Had a very slightly sore arm a few hours after injection through the following morning. Then had a very slight headache for a couple hours. Then the day after that my neck was very sore on the side the vaccine was given. I watched TV on my laptop and had my elbows on my thighs for maybe 30 minutes and I often watch TV like this. When I went to the bathroom, I saw my thighs had multiple bruises where my elbows were (3 spots) while I was watching TV. The bruises and sore neck lasted another 2 days and I was fatigued more quickly during this time. After that I was fine, though 1 bruise spot still remains today 11 days after vaccination. The easy bruising and lasting bruising is not normal for me. I have dark color skin and also rarely bruise.

Within 12 hours, fever chills and body ache. After those passed in a day and a half, deep muscle soreness set in left side. Pain was felt in armpit, chest, left breast, left shoulder and neck. Swollen lymph nodes on the left side that lasted two weeks from the date of the second shot.

11 pm pm 3/17: Developed chills and minor headache. Nausea. Took 600mg ibuprofen. 11:30 PM: developed low fever and body aches. Nausea, 5/10. 1:00 AM: Fever ~101, severe chills 2:30 AM: severe body aches and joint pain 3:00 AM: 103* fever. Chills. 3:30 AM: took 600mg ibuprofen. 6:00 AM: Sweats with 100.5-101* fever. 6-11 AM: Sweats continued. 12:00 PM: sweats and body aches subsided. Nausea and headache 1-2/10 severity. Ate. 2:30 PM: body aches and chills restarted. Nausea increased. 600mg ibuprofen. 3:45 PM: Body aches and joint ache increased in severity.

Throat Swelling, did not really affect breathing, also lymph node swelling, muscle weakness, tiredness. Did stop at doctor's on way home and got high dose benedryl and steroid shot.

Overall achiness, tiredness, sore throat, back pain. Symptoms have persisted since early in the morning the day after receiving the vaccination.

My left hand in the pinkie finger and ring finger are numb ,as well as my right hand is sore and hard to grip very painful, my throat glands are swollen, today I went to pass a bale movement and much strain so I removed it only to discover blood in it. I'm very worried about these health issues that have never been experienced,. March28,2021 Sunday morning bale pass blood seen and noticed around 9:30 am.

Chest pain and swollen lymph nodes for the first week which prevented me from doing my normal activities like exercising. After the first week, I developed knee pain, a cough, and extreme fatigue. I had to miss a day of work on Monday, April 12th due to my symptoms. I slept for 48 hours (Sunday, April 11th 9pm-Tuesday, April 13th 9am) due to my extreme fatigue.

This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 AM (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Historical bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:15 PM (Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD). No covid prior vaccination, no known allergies and no covid tested post vaccination. The patient's concomitant medications included unspecified drug and not enough space. There is no other vaccine in four weeks. Patient experienced adverse events on 02Apr2021 included Arm Pain right after 02:00 AM, Headache around 2am, Nausea around 2:15am, Fainted around 2:20am, Weak Legs around 2:30am, Tingling in hand & feet around 2:30am, ringing in ear around 2:30am, Light fever around 7am, Headache persisting until just now after getting some sleep finally from 12pm-2pm now.AE resulted in Doctor or other healthcare professional office/clinic visit. There was unknown treatment were received for adverse events. The outcome of headache was not recovered. The outcome of other events was recovering.

This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

This is a spontaneous report from a contactable consumer reported for self. Weakness in right hand and right foot; A 28-years-old female patient received the first dose of COVID-19 VACCINE via an unspecified route of administration, administered in Arm Left on 16 Apr 2021 09:45 as single dose for Covid-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Crohn's disease, Psoriatic arthritis, psoriasis, diagnosed with COVID-19 prior to vaccination. Concomitant medications included ustekinumab (STELARA), escitalopram, oral birth control within 2 weeks of vaccination. The patient previously took prednisone and experienced prednisone allergy. The patient experienced weakness in right hand and right foot on 16 Apr 2021 11:30 AM. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was not recovered. The case was reported as non-serious. No follow-up attempts are needed. No further information is expected.

Chills, fever, muscle aches starting approx. 18 hours after shot. Resolved 36 hours after shot. Unexpected menstrual bleeding starting approx. 24 hours after shot - medium flow and then spotting. Normal period had ended 3 days prior. Resolved approx. 48 hours after shot. Have been using Liletta hormonal IUD for 4 years.

On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air pressure,; Slight woozy/dizziness; Injection site soreness; tingly outside of left arm / left pinky; Very mild headache; tiredness; Stiff / sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; slight numbness/ Slight numbness in pinky fingers on both hands, and left toes; General "not feeling good"; nausea; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included developmental trauma disorder, drug allergy, allergies certain adhesives, borderline personality disorder, and irritable bowel syndrome. Patient is not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient experienced very mild headache, and mild tiredness were on 06Apr2021. On 07Apr2021 (day 2), patient was experienced injection site soreness, tingly outside of left arm/ left pinky. During day 6-7 (in Apr2021), patient experienced headache, stiff / sore neck (including upper shoulder area) left side of left arm and leg including hand and foot, tingly and slight numbness, general "not feeling good", slight nausea/ need to lie down, but not fatigue / wooziness. No fever. On 13Apr2021 (day 8), patient experienced slight woozy/dizziness, in waves. Slight numbness in pinky fingers on both hands, and left toes. On 14Apr2021 (day 9), on and off neuropathy in hands and feet, specifically left leg from knee down (outside of left toes and bottom of left foot) and pinky fingers, most notably when falling asleep/ waking up, or after being on my feet for a while. Right ear sensitivity/ "popping", like with changing air pressure, but on and off (most likely unrelated, but during same period). Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment for events. The patient underwent lab tests and procedures which included saliva test: negative on 13Apr2021. The outcomes of events were unknown.

Approximately 5 hours after administration, I developed severe pleuritic chest pain and tachycardia that self resolved after about an hour. This was followed by about 2 days of fatigue and myalgias that interfered with my daily activities that also self resolved. Had a large tender reaction on my left bicep for about 5 days after the injection.

I felt that maybe they administered it too high, like the muscle area of my deltoid, and then around 10PM my shoulder started to hurt and then the next morning my pain level was 9/10 and it was unbearable. I was very fatigued and could not use my arm to work since the pain in the arm. I took some Ibuprofen and took a nap and then after that it got a little better, it still hurt but at least I could I use my arm. The next day it was fine.

Mild nausea (dizziness, tightness in jaw, sour taste in mouth, stomach pain) 5-10 minutes after injection. Muscle soreness at injection site beginning in the evening.

Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.

Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 29DEC2020 09:15 as a single dose for COVID-19 immunization. Medical history included depression from an unknown date and unknown if ongoing, and Covid-19 on '17th of this month ' and unknown if ongoing. The patient had no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), spironolactone (SPIRONOLACTONE), desogestrel, ethinylestradiol (KARIVA). No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. On 29Dec2020 16:30, the patient experienced Arm pain that gradually turned into body pain, joint pain, chills. The pain was so extreme. Patient had Covid on the 17th of this month and was not told that you should wait 90 days after to get the vaccine. The patient reported her response was worse than the side effects of Covid. The events result in a Physician Office Visit The patient was treated for Arm pain that gradually turned into body pain, joint pain, chills with Heating pads, Ibuprofen (Manufacturer Unknown) and Tylenol alternated. The clinical outcome of arm pain that gradually turned into body pain, joint pain, chills was recovered. Information regarding lot number has been requested.

Fever 100.2 chills,Headache, Joint body ache left armpit swelling dime size symptoms started 12 hours later after vaccine

1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain hot sweat chills and diarrhea

Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.

Myalgia, chills, headache starting 1/6/2021 at 6 am Local pain and swelling starting 2 hours post vaccine

Fatigue; Nausea; Headache; Abdominal pain; Muscle soreness (spot of injection, it is better now); This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0140), via an unspecified route of administration on 28Dec2020 at 04:00 PM (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination. The patient had no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient's concomitant medications in the past two weeks included bupropion hydrochloride ER 200 mg and ritual vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020, the patient experienced fatigue, nausea, headache, abdominal pain and muscle soreness (spot of injection is better now). The patient did not receive any treatment for the events. The clinical outcome of fatigue, nausea, headache, abdominal pain and muscle soreness was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Onset of fever, chills, muscle aches/joint pain, headache 11 hours after injection. Fever, chills, and severe muscle aches/joint pain lasted for about 24 hours. Milder muscle aches and headache lasted for about 36-48 hours.

Next morning, I woke up with severe positional headache (headache with standing or sitting up, resolved completely with ibuprofen and tylenol within 20 minutes). The next morning I also had a sore left deltoid, and soreness extending into my left chest and shoulder, which diminished throughout the day after ibuprofen and tylenol. I also had a left swollen armpit, which I interpreted as swollen lymph nodes. My left armpit was sore and was visibly swollen compared to the right. The left lymph node is still visibly swollen as I report this (approximatley 36 hours after vaccine administration), and is sore but less sore than initially. Of note, when I received the first vaccine in this series, my left deltoid was more sore than with the second administration, but soreness was limited to the deltoid and resolved within 3 days.

Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely sore arm with injection site.

~3 hours after injection: soreness at injection site After waking up the next morning: 101F fever, fatigue, muscle soreness, headache

Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative: 12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.

Left axillary lymphedema (swollen under arm pit). Can?t sleep on that side or lay arm flat on that side. Right side is perfectly fine. Slight left neck swelling also. Significant injection site pain with mild redness and swelling. Joint/muscle pain. These events also occurred after my first covid Pfizer but not until day 4-5 and very mild. I have not taken any medication as of yet.

2 hours after receiving vaccine started having severe pain in shoulder. Progressively got worse as the night went on. Jolting sharp pain with certain movements.

Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards of glass. By day 3, swelling in left arm and lymph nodes under arm, armpit, and side of breast. Tingling in left arm down to fingertips and "dead arm" feeling.

Body aches; onset of fever /low grade fever; muscle aches; headache; chills about 11 hours after shot; patient received bnt162b2 first dose on 15Dec2020 16:00 and then second dose on 04Jan2021 14:15; This is a spontaneous report from a contactable other healthcare professional (patient) via Pfizer sales representative. A 29-year-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular first dose on 15Dec2020 16:00 at single dose (batch/lot #: EH9899), and then second dose on 04Jan2021 14:15 at single dose (batch/lot #: EK9231) for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy from an unknown date and unknown if ongoing. No known allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced onset of fever /low grade fever, muscle aches, headache, chills about 11 hours after shot on 05Jan2021 01:00 am with outcome of recovering, no treatment for above events, and patient also experienced body aches on unspecified date with outcome of unknown. The adverse events result in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered non-serious.

Red, hot, swollen arm at and around injection site lasting greater than 48 hours post vaccine administration. Bone pain, lymph node swelling, headache for 36 hours post.

Diffuse Myalgias, chills, low grade fever requiring Tylenol day after vaccination. Now resolved. Round, erythematous, flat, tender area on arm about 2 cm inferior to injection site. First noticed 3 days after vaccination.

Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body aches for 24+ hours, abdominal pain for 2 hours.

Heart burn (severe) unrelieved by tums or pepcid x 3 nights and 3 days Fatigue Malaise Generalized muscle pain and fatigue Mild nausea

Intermittent headache starting one hour post and persisting through the next day. Fever, back ache, fatigue, injection site tenderness, and swollen lymph node to right neck, started morning after vaccine and resolved by second day after vaccine. Took Tylenol twice. Swollen lymph node under right arm, starting morning after vaccination; has reduced but remains present.

Intense pain upon injection not felt with any other form of vaccine. Pain in arm continued to get worse throughout the day. Unable to lift my arm very far without pain. Worse than any other injection recieved in the past. Pain throught the night-causing lack of sleep. Severe pain for about 24 hours or so then completely gone. My muscle in my arm then felt tight as if there was inflammation of some sort or an injury to the muscle. Upon lifting my arm it felt as if my arm was pulling back. No pain during this action but more of a weakness. No relief from anti inflammatory medicaiton or ice. Sensation in arm noted to be gone on 01/09/2021.

Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.

fever, chills, body aches, fatigue, muscle soreness, headache, enlarged/swollen lymph nodes on left side of neck

Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse throughout the day. Temperature at 10:00 pm (14 hrs after injection) was 99.1 degrees Fahrenheit. Went to bed and woke up the next day feeling better. Slight sensitive skin, sore neck, and headache. Did not urinate for 9 hours.

Headache-Tylenol /onset 10 hours after Pain at injection site-onset 10 hours after Fatigue-onset 10 hours after Left side Lymph node pain-onset morning after Joint pain-onset 10 hours after Body aches-onset 10 hours after

Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day. Went to sleep with no issues. Woke up at 2:00am uncontrollably shaking with chills/goosebumps, sweating with shortness of breath. Extreme headache and all over body soreness also at that time. This continued in waves for the next several hours. I finally slept for a short time and woke with continued headache and muscle/joint soreness. This was accompanied by dizziness, nausea and decreased appetite. This persisted throughout the entire next day following vaccination. The day after that was slightly better and the subsequent day I felt relatively back to normal. I checked for fever many times throughout the symptoms but was always afebrile.

I started experiencing chills around 9:00 pm the same day I received the vaccine. I then began having body aches, headache, and joint pain. I did not seek professional treatment but took Tylenol. It is now one day after receiving the vaccine and my symptoms are better but not yet completely resolved.

pain in the left armpit; a small protrusion in the area of the left collarbone which hurts to the touch; a small protrusion in the area of the left collarbone which hurts to the touch; feeling headache; tiredness; chills; bnt162b2 first dose on 15Dec2020 at 14:30 and then second dose on 04Jan2021 at 15:30; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK4176), intramuscularly on 04Jan2021 at 15:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization and had pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00, the next day (16Dec2020) the area was red and inflamed, the redness and the inflammation lasted three days. The patient experienced hours after receiving the second dose of the vaccine she began feeling headache, tiredness and chills on 04Jan2021 at 21:00. The next day of the vaccine on 05Jan2021 she began feeling pain in the left armpit and she had a small protrusion in the area of the left collarbone which hurts to the touch. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.

Pain. It began as lower back pain at 1800 on 1/8/2021. By 0230 1/9/2021 pain progressed. Anterior sharp bilateral pain noted in kidney region (below ribs). Lower back pain continued to worsen. Pain began to subside by 1000 1/9/2021. No pain by 1400 1/9/2021. Tylenol taken. Did not weaken the symptom. Additional signs and symptoms: Headache. Fever (range 99.2-101.6). Lasting 1/8/2021 (0230) through 1/9/2021 (2000). Tylenol taken for all signs and symptoms. every 8 hours. One pill.

body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events. No follow up attempts are possible. No further information is expected.

Myalgia; This is a spontaneous report from a non-contactable physician (the patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on 16Dec2020 (lot EK5730) and second dose on 06Jan2021 at 18:00 (lot EL3246), both in left arm at single dose for covid-19 immunisation. The vaccine was administered at Hospital Facility. The patient did not receive other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient experienced myalgia on 07Jan2021 08:00. The patient underwent lab tests and procedures which included Nasopharyngeal Nasal Swab/sars-cov-2 test: negative on 21Dec2020. No treatment was given for the event. The event was non-serious with outcome of recovering. No follow-up attempts are possible. No further information is expected.

chills; temp of 100.2; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 12:00 PM at single dose for covid-19 immunization. Medical history included none. Known allergies was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient experienced chills, temp of 100.2, and muscle aches on 06Jan2021 12: 00 AM. Treatment received for the adverse event was unknown. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on the lot/batch number has been requested.

she is having a hard time sleeping; swelling; She developed a knot on the side of her neck that was very painful; She does not know if it is a swollen lymph node; right arm pain; pain started traveling up her neck to the shoulder area.; pain started traveling up her neck to the shoulder area; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 24Dec2020 08:30 at the first single dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient received vaccine in Right arm. She got the Pfizer Covid19 vaccine on 24Dec2020. The right arm pain started two hours after getting the vaccine and the arm pain got progressively worse and the pain started traveling up her neck to the shoulder area on 24Dec2020. The patient experiencing Right neck pain and swelling on 26Dec2020. She developed a knot on the side of her neck that was very painful, along with arm pain that went up to her neck on 26Dec2020. The knot developed about 2 days after she got the vaccine and now the knot is getting larger. She does not know if it is a swollen lymph node but she has never had a swollen lymph node in that area, states it is above her collar bone and the knot is very painful. She is thinking to go to urgent care since it is bothering her to where she is having a hard time sleeping. On 26Dec2020 she noticed it was painful in the particular spot where she found the knot. Her arm pain went away by the 27Dec2020 and it was not too painful any more, she clarifies her arm pain recovered completely as of 27Dec2020. The painful knot has gotten worse. The patient did not receive any treatment for the events. The outcome of event right arm pain was recovered on 27Dec2020; outcome of event knot on the side of her neck was not recovered; outcome of other events was unknown.

Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness

I am having chills since last night; Shortness and breathlessness last night; throat is super dry; don't have too much pain in my left arm right where I got the vaccine; Left clavicle that is swollen and painful to touch; Left clavicle that is swollen and painful to touch; Little bit fever; This is a spontaneous report from a contactable consumer reported for herself. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiry date: Apr2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose to get vaccinated to prevent COVID. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and hadn't taken Vitamins yesterday or day before. The patient got yesterday on 05Jan2021 the vaccine and thought that it was a side effect which she didn't have with the first vaccine. She had been having chills since last night 05Jan2021 and little bit of fever in Jan2021. She didn't have too much pain in her left arm right where she got the vaccine but her left clavicle that was swollen and painful to touch in Jan2021. The patient felt like she had a little bit of shortness and breathlessness last night 05Jan2021 but she was fine, her throat was super dry in Jan2021. For lot number, she stated "It is E. I am not sure what the next one is. It might be like a 21284." The patient had taken only pain killers she took two pain killers before she went to bed she took two pain killers when she woke in the middle of night and in morning. For Lab work, she just started feeling like between 12. The outcome of the events was unknown. Information on the lot/batch number has been requested.

The vaccine was given at 12:20 pm 1/9/21 8:30 pm Diahrrea 9:30 pm Exhaustion, body aches, headahce 9:30 pm-7:30 am body aches/muscle aches/joint pain so severe unable to sleep without waking up every hour 7:30 am took Ibuprofen and slept until 3 pm, exhaustion, headache 1/11/21 fever of 100.1 and body aches, headache and exhaustion, took Ibuprofen 1/12/21 back to normal functioning no aches/pains/fever

On 1/6/2021, Felt like she got hit by a train. Fever 102. Body aches from head to toe. Dizziness with intermittent slight rash. On 1/7/2021 she developed severe muscle pain, joint pain, fever, and intermittent lightheadedness and dizziness. She went to the emergency room on 1/10/2021 but no changes made in medications. She reports her BP was 207/111 and her pulse was 165/minute and still runs that high now. She had hypertension and tachycardia. About 1.5 years ago she had a history of hypertension and tachycardia. 1/12/2021 this person continued to have hypertension and tachycardia. Instructed to make an appointment to see her primary physician.

Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours. Arm soreness was quite severe on 1/8, as it was painful to even lift the left arm for much of the day. I also noted, about 5 hours after vaccination, that my jaw felt slightly tense, bilaterally. On Friday, 1/8, I also experienced headache for the entire day, and I was fatigued for much of the day. I noted clavicular lymph nodes as well. About 18-20 hours after vaccination, I developed soreness in my back, and about 24 hours after vaccination, I noted some myalgia in the left leg. These symptoms were responsive to acetaminophen. The headache, clavicular lymph nodes, arm soreness, and myalgias were resolved by the time I woke up on 1/9. Finally, I noted development of an axillary lymph node during the evening of 1/8, about 28 hours after vaccination. This axillary node persisted until Monday, 1/11.

Fatigue staring at 3pm. Muscle aches, chills, and headache starting at 6pm and lasting all through the next day. Persistent muscle aches on the day after

11 hours after administration, I experienced chills without objective fever, myalgias, localized injection site muscle soreness, headache.

At 3PM: fatigue. At 6PM: muscle aches, chills, headache that lasted for the next day. Muscle aches persisted for 2 days.

fever of 38C; severe fatigue and malaise; severe fatigue and malaise; mild headache; Pain in the injection site began within a few minutes and gradually increased reaching it's maximum around 8 hours after the dose.; Neck pain was also significant; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 12:00 PM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 09:00 PM (Arm Right) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included asthma and generalized anxiety disorder (GAD). The concomitant drug was reported as Escitalopram. The patient experienced pain in the injection site began within a few minutes (05Jan2021 12:15 PM) and gradually increased reaching it's maximum around 8 hours after the dose. Neck pain was also significant (05Jan2021 12:15 PM). Fatigue, malaise and mild headache started around 10 hours (05Jan2021 22:00) following vaccine administration. Almost 24 hours following administration (06Jan2021 12:00) a fever of 38 C started and persisted for about 6-8 hours. It subsided but severe fatigue and malaise (that prevent me to do daily activities) are still persisting greater than 48 hours following administration. The outcome of severe fatigue and malaise was not recovered. The outcome of Headache, Pain in the injection site, Neck pain, fever of 38 C, was recovering. No treatment received for the adverse event. No COVID prior vaccination and no COVID tested post vaccination. Information on Lot/batch number has been requested.

Fever, Chills, Severe headache and unilateral left sided neck pain, severe malaise, fatigue, body aches, diarrhea and abdominal cramps

Lymph node swelling to right axillary with pain that radiates to the right breast, down the right arm, and around the back to the right shoulder blade. Pain limited daily activity to the right arm. Pain decreased for about 12 hours and then the pain returned again around 06:00, Thursday 1/14/2021 with lymph node larger than previous day. Area is tender and painful with every day movements. Will consult with primary health care provider if pain/swelling does not improve or gets worse.

Date of symptom onset ? 1/14/21? Symptoms - ? EE reports she woke up at 06:30 with body aches, mild headache and back pain. EE reports she took 400 mg motrin at 0700 and came to work. EE reports around 09:00 worsening HA and nausea. EE took her temp (99.1) and took 1000 mg Tylenol. EE advised by manager to call vaccine support line for recommendations. Last day of work and shift - ? EE currently at work Home remedies? ? see ?symptoms? for narrative Any improvement? - mild Recommendation? EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE denies covid-19 exposure without proper PPE and denies travel. EE does not meet criteria to be COVID tested at this time. EE educated to continue to manage per TCH Illness in the Workplace Policy and to notify manager if she needs to leave work today. EE verbalized back understanding and denied further questions at this time.

1 week history of significantly worsened (previously present "low back strain" lower back pain that had become radicular to both LE and associated with progressively worsening bilateral LE weakness, paresthesias since COVID vaccination last week. see continuation for HPI and assessment/plan from office note 1/13/21 HPI from OV dated 1/13/21 She had presented initially in December 2020 for her annual physical, and we evaluated some low back pain that that time, felt to be a sprain/strain resulting from a fall in the shower earlier December which was aggravated significantly by lifting/transferring a patient at the SNF she works for as a nurse. Presentation at that time was rather benign, no imaging obtained, pt was placed on leave from work for 1 week to avoid the heavy lifting and likely aggravation of back pain, and rx including diclofenac and cyclobenzaprine. She did not FU in the office, but returned to work at SNF a week after I saw her for the back pain. She states she had improved enough to feel like she could go back to work but wasn't 100% without back pain yet. At no time was comp mentioned at the visit in December. She did tell her employer about the injury and was off of work for a week and was encouraged to seek comp. We were never notified. Yesterday 1/12 she followed up in the office for the back pain and was found to have much more severe pain, now radicular to both LE (pain intensity worse on right), with new neurologic impairment including objective weakness bilateral LE (R>L), sensation disturbance bilateral LE (R>L). Xray of lumbar spine obtained in clinic, this was essentially unremarkable, non-acute. Pt was sent for stat MRI of the lumbar spine. MRI last night revealed no findings to explain her severe symptoms - she has mild symmetric disc bulging at L5-S1 nd mild bilateral facet arthropathy with patent canal and foramina, and a mild nonspecific "STIR signal abnormality" within the soft tissues abutting the left lateral aspect of the L5 spinous processes felt to be small and nonspecific. I did discuss the case and the imaging with the radiologist and he feels this is unlikely to be the source of her back pain/radicular symptoms. No obvious signs of apparent discitis or any signficant soft tissue abnormality. Pt contacted last night with initial "normal" results of MRI as formal results were pending - hydrocodone was sent to her pharmacy for pain relief overnight. Pt received 60mg toradol in the office yesterday during her visit. Pt noted significant improvement in her back pain, bilateral leg pain about 30 minuts after that injection. She continued to have pain in the evening but went to sleep. She woke at 3am unable to roll over due to weakness and pain - her sister gave her a hydrocodone and she went back to sleep' she woke this morning feeling much better; today, she has less severe low back pain, less severe right lower leg radicular pain, NO pain radiating into the left LE, lessening of the weakness in her right LE, lessening of paresthesia reported in the right LE (now isolated just to the heel), resolution of the weakness in the left LE, resolution of the tingling of the left knee. Other than the toradol and one dose of hydrocodone, no other medications were given, no other treatments given since presentation yesterday. Upon further questioning, patient does reveal that she received the 1st of 2 COVID-19 vaccinations (pfizer) last week. She received the vaccination at work at nursing home on 1/7/21. She had some relatively quick onset nausea and dizziness within an hour of the injection, but that resolved. She recalls feeling like her low back pain, bilateral lower leg pain, leg weakness and paresthesias all intensified sometime either Wednesday 1/6/21 or 1/7/21, but more obviously worsened over the weekend 1/9 and 1/10. Along with the lower extremity symptoms, she does admit today that she experienced soreness in bilateral upper arms starting the day following the vaccine administration, with left arm/shoulder still feeling sore and tender to the touch now. She also developed some altered sensation of the right thumb and index fingers the day following vaccination (1/8/21) and this has been persistent/unchanged. She is right handed. No prior issues with right hand/fingers. Other than the altered sensation, she denies pain, swelling, or notable weakness. She is right handed, and really hasn't done much with her right hand over the past week since she hasn't been working. Patient denies having significant headache, fever, chills, diaphoresis, fatigue, rashes/injection site erythema since the covid vaccination. She was not told to sign up for or told about the V-safe program and hadn't thought to report her symptoms to work or think to be concerned regarding possible vaccine SE. Pt denies prior hx of low back pain, neurologic symptoms including weakness/paresthesias, previous allergy to or adverse reaction to vaccination or injectable medications. She has a history of latent TB(fully treated) but is otherwise in good health. After gathering much further detailed information/history today from patient, review of chart including the MRI results and xray results from yesterday, my prior OV note, and discussion with radiologist today regarding her MRI - I Discussed with patient and her sister that I believe what is becoming more apparent to me now is that she is likely suffering from an adverse event associated with the COVID-19 vaccination she received on 1/7/21 through her workplace. I'm unable to define this for certain, but I suspect that she developed the progressive worsening of low back pain, development of radicular pain and bilateral LE weakness and paresthesias about 1-2 days following the vaccination administration. She has had notable and rather surprising improvement in both subjective and objective findings Today as compared to yesterday. Only intervention was toradol 60mg IM and one dose of hydrocodone, she had already been taking diclofenac or ibuprofen so I believe the only explanation for the improvement over the past 24 hours is the fact that she is gradually having resolution of the temporary paraparesis, neuralgia, paresthesia brought on by the recent COVID-19 vaccination. I believe she truly had injury to the low back in December, initial injury at home but had improvmenet and then significant worsening/exacerbation when transferring a resident at work. Her presentation following that was consistent with a strain/sprain of the lumbar spine. This was treated appropriately with rest, activity modification, stretching, NSAID, and muscle relaxers. She returned to work w/o restriction likely earlier than she should have but I believe the covid vaccination is likely what caused her condition to so significantly decline; Its also possible that her physically demanding job requiring lifting/transferring/standing for prolonged periods of time on top of an only partially resolved low back strain had aggravated her low back condition. plan from OV dated 1/13/21 Given the improvement since yesterday, I recommended obtaining some labs looking for any sign of alternative explanation including infectious etiology or autoimmune/inflammatory condition, however will hold on further imaging as would be the plan, specifically EMG of the bilateral LEs. Explained to patient that I'm hopeful with continued rest and time, her symptoms (weakness, tingling/numbness, radicular back pain) will completely resolve. She may need some eventual PT for the disc bulge in the lumbar spine and lumbar strain that is likely still lingering. Will contact pt with any change in care plan based on the laboratory findings. I would like to closely follow her, and make sure her symptoms continue to slowly improve /resolve. If at any point she develops worsening symptoms again or any new neurologic signs/symptoms (and we discussed what emergency signs/symptoms would be) then she needs to be in touch with me right away. I will work on reporting this suspected adverse covid vaccine reaction to VAERS / possibly also CDC and see if they have any additional input/suggestions for monitoring/treatment. For pain control, pt may continue with the diclofenac OR ibuprofen, and the hydrococone/APAP as needed for breakthrough severe pain uncontrolled with the NSAID. I have advised pt to remain off of work at this time, resting at home avoiding lots of physical activity as she continues to heal. Suspect will have her follow up in clinic sometime next week for repeat evaluation/examination depending on VAERS/CDC recommendations and of course the lab results and any updated condition reports from the patient in the interim. Will want to make sure she has full resolution of the paresis and adequate resolution of her back pain/radicular pain prior to returning to work, even in a limited capacity. I am informed today that there is light duty available and will keep that in mind. Pt to be contacted regarding follow up. Encouraged to call with questions/concerns/updates. Pt was very thankful for the care.

I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I started feeling a little tired and some pain around the injection site. I had anticipated this as I felt similar symptoms from the first dose of the vaccine. I took a nap and woke up around 09:00pm feeling some of the worst body aches I had felt in a long time. My arm that I received my vaccine in was painful and warm to the touch. I felt dehydrated as well so I drank a pedialyte, took OTC Tylenol extra strength, and laid down again. Around 07:00am on 1/13/21, I still felt achy, sweaty, and felt pain in the arm that I recieved the vaccine in. I went into my bathroom, and noticed two small red and raised areas around the injection site. I took pictures of the site, and continued to closely monitor through out the day. I ended up calling in sick to work on 1/13/21. It is now around 12:00pm on 1/14/21, and I woke up with a pounding headache, muscle aches, dehydration, nausea, and low energy. I feel like I am hungover or have the flu, and am planning on calling in sick to work again. I reported my symptoms to my staffing department at my workplace on 1/13/21 and wanted to file a report here as well.

Myalgia; Chills; Nausea; Joint pain; Headache; Fatigue; This is a spontaneous report from a non-contactable pharmacist (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 06Jan2021 18:15 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EL0140, expiry date not reported) in the right arm on 18Dec2020 at single dose for COVID-19 immunisation. On 07Jan2021 at 02:00, the patient experienced myalgia, chills, nausea, joint pain, headache and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on 08Jan2021 at 02:00. No follow-up attempts are possible. No further information is expected.

Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Start Date/Time: 08Jan2021 12:45 PM/ Start Date/Time: 21Dec2020 10:15 AM; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date not reported), intramuscular in the right arm on 08Jan2021 12:45 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the right arm on 21Dec2020 10:15 at single dose for COVID-19 immunisation. The patient experienced significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose. No treatment was received for the adverse events. Clinical outcome of the events was recovering.

whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.

Severe chills, sweats, fever like symptoms with headache and muscle fatigue starting at 2:30am at night and lasting all night. Symptoms became mild for the next 24 hours but lasted till next morning in a more mild fashion.

Around 2 AM on 1/15/21 (about exactly 12 hours after receiving the 2nd COVID vaccine injection) I woke up with severe chills and had a fever of 102 degrees F. Also had joint pain in knees/ankles and thigh muscle pain, as well as injection site pain. Around 9 am, fever had increased to 104.4 degrees F. After taking 1000 mg of Tylenol, fever decreased to between 100 and 101 degrees F. Around 3 pm, fever was still above 100 degrees F so took 400 mg of ibuprofen. By 5 pm, fever was finally below 100 degrees F. By 1/16/21, all side effects had resolved except lymph node in injection arm was significantly swollen, hot, and tender. By 1/17/21, side effects still resolved besides swollen and tender lymph node.

Headache; Nausea; pain at the injection site; Fever; Chills; body ache; Fatigue; tingling/numbness at injection site; tingling/numbness at injection site; shoulder stiffness; altered taste; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 08Jan2021 at 11:00AM at a single dose (dose number: 2) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced swelling at injection site, inflammation around injection site. No Known allergies (allergies to medications, food, or other products) and no other medical history. It was unknown if the patient was pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced headache, nausea, pain at the injection site, fever/chills, body ache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste - after 2nd dose. Events with start date on 08Jan2021 at 11:30 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.

10 hours since second vaccination I had muscle aches, chills, myalgia, nausea, headache, and fatigue. This went on for.36-48 hrs. After flu like symptoms subsided,I started to get pins and needles in both feet, legs, and hands. Then twitching and muscle spasms in my legs.

About 12 hours after the vaccine, I started having arm pain at the site and low back pain which is very unusual for me as well as a dull headache which is not uncommon for me. Around midnight I woke up with chills, and severe arthralgias in all joints down to the toes and fingers, and deep, boring pain in my long bones and neck. My skin and fingertips felt like they were burning. I was nauseated but didn?t vomit. I was up all night because I couldn?t find a position I wasn?t in pain in. Tmax 100.3 F. Took a gram of Tylenol with improvement of symptoms. Felt better in AM but when Tylenol wore off around 9 am, had another wave of the same pain all over. Tylenol improved. Felt almost completely normal by 4 pm with the exception of some lingering low back pain (central not muscular).

fever 100.2 chills,Headache, Joint body ache left armpit swelling dime size symptoms started 12hours later after vaccine

Second dose of COVID vaccine (Pfzier/BioNTech) received Friday morning around 8:00, I left work about an hour early that day due to rising nausea, migraine and fatigue. By the time I got to my car in the parking garage I had thrown up and was so dizzy that I called my boyfriend to come pick me up. When I got home I immediately laid down to take a nap. 3 hours later I woke up very sore and achy and still had a migraine. I remained in bed and later that night I spiked a fever as high as 101.8 fahrenheit. I had severe chills and the aches were so bad that my bones hurt all over and it felt like someone was stabbing me with a metal broom handle. Pain spiked to 8 on the pain scale and with the length of time I had this pain, it was one of the worst experiences of my life. The dizziness and fatigue caused me to need help to get out of bed to use the restroom. I took ibuprofen frequently and Nyquil at night to help relieve the effects without it doing little more than taking the edge off. Saturday night was the same as Friday night with no relief of symptoms. Fever remained around 100.9. Sunday night it dropped to 99.8 with chills, dizziness and fatigue still remaining but aches slightly lessening. Monday night I was still dizzy and weak but not nearly as in much pain and fever had subsided. Tuesday I started to feel more normal by the end of the night, just easily out of breath and off and on again headache.

AE's : Injection tenderness, fever, chills, headache, malaise, severe myalgia, lymphadenopathy, mild sore throat, occasional nausea and lightheadedness when standing for longer than 5-10 minutes at a time. Tx: none Outcome: All AE's except injection tenderness and right axial lymphadenopathy fully resolved within 48 hours.

fatigue; Severe fever (104.6); chills; nausea; muscle soreness; first dose of BNT162B2 on 22Dec2020, second dose on 09Jan2021; This is a spontaneous report from a contactable nurse. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 09Jan2021 at 07:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other product. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) on 22Dec2020 at 02:00 pm on the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Jan2021 at 20:00, the patient experienced fatigue, severe fever (104.6), chills, nausea, and muscle soreness. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.

About an hour after receiving the vaccine I began to feel a little dizzy, tired, and started to develop a headache. By the next day my headache became overwhelming and the the dizziness became so pronounced that I could not stand for more than 5 minutes at a time. I a had an intolerable headache on the entire bottom of my head that made my neck start to hurt. I felt nausea that did not improve until four days later. My joints were hurting sharply two days after the immunization and lasted two days. Most of my symptoms improved on the 13th of January, but were still lingering. About 5 days after the shot my symptoms resolved completely.

I experienced a lot of fatigue, muscle pain, headache that progressively got worse during the day, body aches, chills. This lasted from 9am through the entire day. The headache became a lot worse around 3pm that day and I noticed a peak in these symptoms around 1pm.

First Dose- I had a headache after the shot and tremors started that even and throughout the night. No fevor. Arm very sore, going into neck. Second Dose- Felt find the night. Woke up that morning at 1am and with tremors and in a night sweat. Checked temp and it was only 96, but felt hot and was sweating. Woke up the next morning and my entire body, muscles and joints ached. My knuckles, ached, kept getting sharp pains in my knuckles. My jaw ached, difficulty eating. My entire body, my muscle ached, difficulty moving. I didn't get a headache till that evening. I also had severe heart burn that night, not sure if it was related, but I have never had heart burn that bad. The next morning when I woke up (5am) (now two days after my shot), again my joints hurts, I couldn't even stand. Its like my knees couldn't even support me and I had a massive headache. I went back to bed and woke around 9am, no longer had a headache, muscles still hurt. Around 11am, all of a sudden, muscles and joints felt fine. The only thing (day three) is my arm pit on my left side where i got the shot is bothering my extremely bad. I was able to put an ultrasound probe on my axilla area, and I have swollen lymph nodes in my axilla in the area that is very painful. I also have a dull pain in my elbow.

Pain on area of injection so bad I can?t move or use my right arm. Started around 7:30pm the day of the vaccination. Day after vaccination I have fever, nause, joint pain, chills, and the pain in the arm persists.

Pfizer-BioNTech COVID-19 Vaccine EUA fever, chills, nausea & vomiting, muscle aches, bone aches, headache - lasted about 8 hours

12 hour post vaccination starts shaving chills and mild myalgias. Took Tylenol with low grade temps. Overnight worsening myalgias, febrile to 101, nausea, headache despite Tylenol.

I started to experience back pain and light spasms two to three hours after the second vaccine shot. When I woke up the next day I was unable to move. I have had intense back spasms which make it hard to; walk, pick up items, and walk up/down stairs. I have been bed ridden since I received the shot getting up to eat and do light stretching.

Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.

Day of vaccine a few hours later I had a migrane start to form and I felt off. Sunday morning the migrane had ebbed a bit until about 12 noon. By that point I was in bed almost all day with muscle pain in my torso (back, ribs, abdominal). I also had a severe migrane and a fever that at it's worst was 102.3. It was brought down quickly with ice to 100.7 within an hour. After about 8 hours it subsided for about 20 minutes before the torso pain and migrane came back. The fever stayed around 100.3 when I last checked. I went back to sleep for the rest of the night and felt fine in the morning with no fever.

1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness

Approximately 10 hours after receiving 2nd dose of vaccine, onset of moderate joint pain, headache, body aches and chills noted. Symptoms persisted for 16 hours without intervention of medication. After 16 hours, symptoms were alleviated with 2 doses of 1000mg acetaminophen taken 6 hours apart. 1st dose at 11am on 1/26/21 and second dose at 5pm on 1/26/21

Once patient in waiting room, after a few minutes, patient verbalized feelings of dizziness after receiving Vaccine in L arm. Given apple juice. Transferred via wheeled chair to private holding/monitoring room. Patient transferred onto gurnee. Pt began to complain of pain and feelings of heaviness in Left arm, given more juice and crackers to eat. Verbalized dizziness occurred with first dose, but one day after receiving. Patient states mild pain began at bridge of nose as dizziness begun. VS at 1845: BP of 126/82 in R arm. Heart rate 83bpm, Pulse ox 97%. HOB lowered to 45 degrees per pt request. At 1900, pulse ox 97%. Heart rate 77; B/P 120/80. Verbalizes lesser feelings of dizziness now, but still present.. At 1915 pulse ox 97%. heart rate 73bpm. B/P 126/80. Pt sat up to 90 degrees. Verbalizes tingling remains L arm. at 1920 patient able to stand up without dizziness, ambulate, and only c/o L arm soreness now. Ambulated in hallway twice before sending home. Patient stated she was Covid+ in October 2021

Swollen lymph node to right axillary; Swollen lymph node to right axillary. Pain radiates to right breast, down right arm and around to the back and right scapula area/ tender to touch; Pain radiates to right breast; Pain radiates to right breast, down right arm; Pain radiates to right breast, down right arm and around to the back; Pain radiates to right breast, down right arm and around to the back and right scapula area; Pain caused inability to do daily activities; This is a spontaneous report from a contactable nurse (patient). A 29-years-old female patient ( received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 12Jan2021 07:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient had allergies to sulfamethoxazole, trimethoprim (BACTRIM), amoxicillin. The historical vaccine included the first dose of BNT162B2 at right arm on 21Dec2020 07:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node to right axillary, pain radiates to right breast, down right arm and around to the back and right scapula area, pain caused inability to do daily activities and area was tender to touch from 13Jan2021 02:00. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the batch number has been requested.

Migraine started 2.5 hours after receiving shot (2nd dose). Intense migraine with nausea, hand and facial tingling/ numbness, seeing spots. Went away at just about 24 hours after it started. Got the chills just before it went away, no fever. Skin sensitivity and fever set in around 26 hours in - 102. Heart rate jumped from 130-170. Improved to about 150 with Tylenol and ALOT of fluids as fever improved, remained high until fever was gone around noon the next day. Hip pain, neck pain and back pain throughout. Hip pain first 24 hours. Back pain following that.

fever; chills; severe headache; severe muscle and joint pain; chest tightness; mild nausea; lungs felt inflamed, making it difficult to take deep breaths; unable to sleep; severe muscle and joint pain; This is a spontaneous report from a contactable health care professional (patient). A 29-year-old female patient recived the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EK4176) via an unspecified route of administration on 12Jan2021 at 08:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL], manufacturer unknown), vitamin B12 (manufacturer unknown), vitamin c (manufacturer unknown), melatonin (manufacturer unknown), biotin (manufacturer unknown) and elderberry [sambucus nigra] (manufacturer unknown). The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EJ1685) on 22Dec2020 at 9:00 PM on the left arm. The patient did not receive other vaccines in four weeks. The patient reported that after her second dose, she began experiencing severe side effects around 5:00 pm the same day (about 7 hours after the dose was administered). These side effects were fever, chills, severe headache, severe muscle and joint pain, chest tightness, and mild nausea. She also added a difficult symptom to describe, but her lungs felt inflamed, making it difficult to take deep breaths. These symptoms lasted for 36 hours unabated, and she was unable to sleep, go to work, eat, or go about daily activities during this time. After 36 hours, the fever, chills, headache, and nausea subsided, but the muscle and joint pain and chest tightness persisted. It has been 50 hours since her second dose and the muscle and joint pain and chest tightness still persists, although its severity is reduced and it is not preventing her from work or daily activities. The patient did not receive any treatment for all the events. The outcome of the events severe muscle and joint pain and chest tightness was not recovered while the outcome of the other events was recovering.The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.

Fever of 99.5 for approximately 2 hours muscle aches in back and legs for approximately 7 hours mental fatigue ?cloudy? thinking, still coherent and oriented, congruent with typical ?sickness? approximately 7 hours

Mild itching, fatigue, rash, muscle aches. Moderate headache. Patient described rash as red blotchy spots on forehead and sides of her temple. Ears also were hot to touch.

"Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan. 20th, 2021. On Jan. 21st, 2021, I woke up feeling feverish. I went to use the bathroom, and after washing my hands I walked towards the bathroom door and felt light-headed and dizzy. Suddenly, I passed out and hit my head and upper neck on the tile floor. My parents heard the sound of my fall and luckily rushed to the bathroom. They found me lying unconscious on the floor with my eyes rolled up for what felt like more than a minute. I regained consciousness on my own, and I drank water with a bit of sugar and salt mixed in. I felt too weak to get up and walk, and the back of my head and upper neck were in pain. I told my parents to call 911 as I wanted to make sure that there was no serious damage to my brain or neck area. I went to the local hospital in an ambulance. I was taken to the emergency room: Vitals were done and my temperature ranged from then was 99.5-101F and my heart rate was high- it stayed around 112 bpm for some time I was given 2 L of IV Saline Fluids EKG result: no clinical abnormalities CT head/neck/spine: negative 2 different types of COVID-19 tests: results were both negative Bloodwork: CBC/BMP/D-dimer: no clinical abnormalities Chest Xray: negative 2D- doppler ultrasound: negative Holter monitor: negative for irregular heart rhythm I was discharged the same day around 4:30pm

Fever, rigors, severe nausea, headache, generalized weakness, body and joint aches. These lasted 10 hours. Total 4 days of significant fatigue, joint aches, neck stiffness.

First vaccine I had slight fever/ chills. Second vaccine on 01/27/21 I woke up next day with extreme body aches and a temp of 101.1. Going into today 01/31/21, I still have elevated temp been taking Ibuprofen and Tylenol but now having dizziness, left facial pressure/pain, and nausea with neck stiffness.

Fever of 101.1 degrees Fahrenheit; rigors; body and joint aches; body and joint aches; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: Ek4176), via Intramuscular on right arm on 16Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 29 years old on 25Dec2020 (first dose, Lot number=EH9899, 10:00 AM, Intramuscular on Right arm) for covid-19 immunisation. The patient experienced fever of 101.1 degrees Fahrenheit, rigors, body and joint aches, headache, fatigue 12 hours after vaccination on 16Jan2021 at 10:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. The patient underwent lab test included COVID 19 PCR on 17Jan2021 (covid test result: Pending). The outcome of the events was recovering.

Fever, Chills, severe Headache, fatigue, weakness, nausea, vomiting, back pain, mouth ulcers, UTI, body aches, muscle pain, dizziness, etc.

Immediately following vaccination no adverse reactions occurred. Approximately 8 hours following, I began feeling sluggish & global muscle soreness. I slept that evening with Tylenol in my system(1000mg) and then awakened the next morning with swollen & tender axillary nodes in my right upper extremity. I rested that day due I was still feeling bad(fatigue, muscle & joint pain, headache) with alternating 1000mg of Tylenol and 600mg Ibueprofen every 4 hours. January 31st morning I awoke and continued to have the swollen, tender axillary nodes with progression of swelling into my right breast and down into my right elbow area. I again alternated NSAIDs with no improvement except for lying supine with my RUE elevated toward the ceiling. Monday morning I continued to have the same above symptoms and Tuesday my RUE is swelling into my hand intermittently with continued tenderness & swollen axillary nodes. I see a physician on Thursday at 1330, Dr.

Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection. Received vaccine at 9:15 AM. She initially felt well, but about 20-30 minutes after administration began to feel dizzy. Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration. Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx. However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain. By 11:08 no longer had symptoms except for arm pain. By 11:43 still feeling back to normal except for arm pain.

Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Nausea; Vomiting; Severe myalgias; Headache; This is a spontaneous report from a contactable physician reporting for herself. A 29-years-old female pregnant patient received the second dose of bnt162b2 (BNT162B2), lot number EL0142, via an unspecified route of administration from 18Jan2021 15:00 (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination. Historical vaccine included first dose of bnt162b2 (BNT162B2), lot number EL1284 in the left arm. The patient's medical history was not reported. Concomitant medication included multivitamin. The patient previously took clarithromycin(BIAXIN) and experienced Known allergies: BIAXIN. No other vaccine was given in four weeks. The patient received the vaccine at a hospital. The patient's last menstrual date was 23Nov2020. Her Delivery date is 01Sep2021. Gestational period is 6. The mother was 8 Weeks pregnant at the onset of the event. On 19Jan2021 at 03:00 the patient experienced nausea, vomiting, severe myalgias and headache. Treatment included acetaminophen (TYLENOL) and antiemetic. The clinical outcomes of the events nausea, vomiting, severe myalgias and headache was recovering. The clinical outcome of the event "Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event" was unknown. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.

Received 2nd Covid vaccine dose on 01/31/21 at 07:13 AM. The evening after/bedtime after injection - Had severe chills, mild fever (highest temp 100.3F), myalgias/body aches, and aching/pain and burning in collar bone area. 02/01/21 at 04:00AM - still having above plus even more discomfort over collar bone (especially left side) noticed lump over left collar bone which was an enlarged left supraclavicular lymph node which was also very tender. 02/01/21 - called my primary physician, notified them of the above info and Appt scheduled for 2:00PM. Went to Appt for physician evaluation on 02/01/21 at 2:00PM. Follow-up Appt scheduled with Primary Physician for Thursday 02/04/21. Today 02/02/21 - lymph node remains enlarged and tender. Fever chills and body aches have subsided for now. Having headache today as well.

Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 195/110 ) leg pain, muscle aches

muscle aches; joint pain; chills; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 29-years-old female patient received Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK9231, via an unspecified route of administration on 28Dec2020 12:15 (at age 29 years old), as a single dose in left arm; and Dose 2, Lot# EL3247, via an unspecified route of administration on 20Jan2021 10:15 (at age 29 years old) as a single dose, left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included generalised anxiety disorder, obsessive-compulsive disorder, asthma, and food allergy (citrus, berries, tropical fruits, ascorbic acid, dill, crab, tree nuts, peanuts). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), alprazolam (XANAX), diphenhydramine hydrochloride (BENADRYL), and ibuprofen. The patient did not receive any other vaccines in the 4 weeks prior to COVID vaccination. On unspecified dates after both first and second doses, she had muscle aches, joint pain, chills, and nausea. There was no hospitalization or treatment received for the events. The events were reported as non-serious. The patient was recovering from muscle aches, joint pain, chills, and nausea. Since the vaccination, the patient has not been tested for COVID-19.

Abdominal pain, diarrhea, pain in joints, tiredness, nausea, pain in the chest, chills, nasal congestion and discomfort in the throat.

PMH: dx with Grave's disease in 2014, s/p thyroidectomy 2/2 thyroid cancer on 8/10/2020 (now on synthroid 150 mcg). 1/26 ED VISIT: P/w chest pain/SOB went to ED. Patient received the COVID vaccination 3 days prior (1/23). Was in NSH the morning of vaccine, then in the afternoon became tired. Then developed a H/A (frontal and right sided, that has resolved) and chills. p/w SS chest pain, radiating to the right shoulder and to the back. Worsened with deep inspiration and difficult to take a deep breath. Took tylenol at 8 pm yesterday (1/25) and advil at 1 pm yesterday (1/25). A/w DOE. Denies birth control use, n/v, abd pain, urinary symptoms, tobacco/etoh/drug use, recent travel, cough, le swelling, hx pe/dvt. Patient had imagining completed - no significant findings and discharged on percocet and ibuprofen. Patient represented to the ED on 2/2/2021: Over the last two days, patient has tender right shoulder pain radiating to neck and chest with ROM and strength limited by pain associated with nausea. Evaluate for rhabdo and myocarditis - negative. Patient seen by ortho (note unable to be obtained). 2/4 Telehealth visit: The patient reports still having a swollen lymph node under her left axillary area. She denies fever. Patient reports pain to her right shoulder. She presented to ortho who said it might be an infected cyst and attempted to drain it unsuccessfully. Patient mentions pain and tingling to her left breast. She notes right shoulder pain to the back of her neck that radiates down to her left arm. She notes a stabbing back pain and rib pain when she takes a deep breath. Patient given levofloxacin and gabapentin

After the vaccine was administered, 5-10 minutes later I began to feel a rapid heart rate. One of the nurses came to check on me, I described to her my symptoms, and she let me know if they get worse to inform her. In the next 5 minutes, my head began to hurt, as well as, some chest pain. She checked on me again, and said to let her know if things got worse. Within the next 5-10 minutes after, I had difficulty swallowing and speaking. I raised my hand, and the nurse came over, then proceeded to get help. They then took my blood pressure and heart rate. My blood pressure was 185/103 and I believe my pulse was 156 bpm. I was still having a hard time swallowing and speaking. They proceeded to get an epi pen and the doctor on site, as well as suggested to send me over the ER/ call 911. The doctor checked my lungs, and they noticed my blood pressure and heart rate was not decreasing to a normal level. I was then put in a wheel chair and transferred to the ER. At the ER, my blood pressure and heart rate was still elevated, as well as difficulty swallowing. The doctor ordered Benadryl via IV, steroids, and the epi pen. After having a reaction to the Benadryl, the epi pen was put on hold. After about 15 minutes, I began to feel better. I was put on IV fluids and observation. I was able to leave the ER around 12 pm 2/05/21. At this time, 7:22 pm, I am feeling better with mild muscle aches, and fatigue.

32 Weeks pregnant Due Date: 4/1/2021 1st child About 8 hours after I started with nausea and a little fatigue. I woke up the next morning with joint and muscle pain. That lasted a full day along with the nausea. I did take Tylenol, it didn't take it away but made it more tolerable. This lasted for about two days.

Mouth swelling; hives in mouth and lips; Body aches; joint pain; chills; This is a spontaneous report from a (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration in left arm on 14Jan2021 11:45 at first single dose for COVID-19 immunization. Medical history included covid-19 (covid prior vaccination), known allergies: Penicillin, sulfa drugs. There were no concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced body aches, joint pain and chills began about 16 hours after receiving vaccine (15Jan2021). Mouth swelling and hives in mouth and lips began 4 days after (18Jan2021 10:00 AM). AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment included: prescribed steroids. Covid was not tested post vaccination. Outcome of the events was recovering. No follow up attempts are possible. No further information is expected.

Morning of 14th, I woke up and my left arm hurt to move - it wasn't the site itself, it was under my armpit (where the lymph node is). I didn't call my doctor at that point because I read that it was a side effect. Dull/always there pain at that point. On the 15th, shooting pains - this lasted two days. It started getting better again by the 17th. It was resolved by the 18th. 14-17th - Swelling that I could feel and see and that also went back to normal by the 18th. It was just tender to touch for a little while after that....after it didn't hurt to move I didn't pay as much attention to it. I was able to go to work but I had to modify what I could do at work. I could not do my normal swimming exercise until that next week.

Approximately 4 minutes after receiving my vaccine I felt warmth down injected arm. Approximately 20 minutes post injection, I experienced a drop in my blood pressure, heaviness in my legs (like walking through cement), and ringing in my ears. At approximately 12:30-12:45pm I experienced mental fog (I couldn't remember how to turn off my windshield wipers), increased heart rate, rapid onset of feelings of panic, minor shortness of breath, neck/clavicle tightness on side of injection, and sweating. Between approximately 1:30pm and 2:30pm I continued to have extreme sweating, as well as: increased pulse, fatigue, dry throat, muscle weakness/shakiness, brain fog, and headache. At approximately 3:30 I hit my knee on the bed frame and felt like the wind had been knocked out of me and immediately had a severe drop in blood pressure that felt similar to a vasovagal event. I called the vaccine clinic and my symptoms were noted and I was told to seek help if my symptoms worsened or I felt like I was going to pass out. My symptoms have not worsened but I am still experiencing extreme sweating along with shivering, shakiness, blood pressure changes with movement (orthostatic hypotension), and fatigue - time is currently 5:50pm

anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.

developed severe left sided neck pain and swelling and left arm pain on 1/24, swelling under left armpit as well

Joint pain in already inflamed joints Body aches Swollen lymph nodes in armpit of arm where shot was received

Onset ~1.5 hours following dose of significant muscular tightness of bilateral cspine paraspinals and severe fatigue that lasted ~36 hours.

2/18/2021 4:30am woke up nauseous, having muscle aches from injection site in left bicep to top of head on same side, not able to think clearly ?foggy?. 1:30pm having muscle aches in both sides of neck and headache left sided

High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache and dizziness, shaking, muscle cramps (all lasted about 24 hours straight through. Muscle and joint pain and weakness continued through 48 hours. Left arm, under arm and shoulder were very tender and mobility restricted through day 3.

numbness and tingling in R arm and neck. Then next day when I followed up with patient the numbness and tingling had resolved and she stated her neck and R shoulder blade area were sore.

Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder control Admitted to hospital 01/24/2021-1/26/21. Not diagnosed. Had 4 MRIS and a lumbar puncture 02/3/2021- was in ED at hospital due vision issues/double vision- discharged same day. Repeated 4 MRIS and blood work, and lumbar puncture. 02/09/2021- patient was seen at a neurologist, due to numbness in bilateral hands and arms. And was admitted to Medical Center until 02/13/2021. Ruled out MS, GB, repeated 4 MRIS and LP. Was sent home with home health and PT. Saw PCP 02/19/2021, Did paperwork for disability and removed from work until 04/30/2021. PCP ordered more blood work up to 35 tubes of blood done on 02/17/2021. Will not be ready until 14 days post draw. Patient is still complaining of tingling on bilateral hands and feet, and weakness. Mainly sensory nerves related symptoms.

Fatigue, cold sweat/chills, slight headache, muscle/joint pain, skin painful to the touch (typically occurs to me right before getting a fever or becoming sick)

She developed flu like symptoms the day after receiving the vaccine, including, fever, chills, nausea, vomiting, fatigue, myalgias, rash, which have persisted for 6 days.

Bell's Palsy -loss of muscle movement in left side of face, numbness in tongue, pain in neck. Began on 2/18 with numbness, woke 2/19 with no control of facial muscles Received steroids and antivirals, no improvements

Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes, sore arm. These symptoms lasted about 2 days total.

Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to walk on feet and use hands.

Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. After about 20 minutes the numb like feeling had begun to regress back toward the injection site. It had not fully faded away after 30 minutes but did seem to be improving.

Fever, swollen lymph nodes, itchy skin, intense body acne (increased swelling and discharge from existing infections), muscle aches, body pain, prolonged fatigue, brain fog, persistent migraines, sweating, chills. All persisted for about a week.

2 Days post injection started to have left axillary lymph node pain and swelling. Left arm sensation starting to become cold, tingling, and numbness. 1 week post injection right axillary swelling and pain started. Right arm sensation also started to have cold, tingling, and numbness but not as extreme.

Woke up with achy upper back (~18hrs post vaccine) and low grade fever (99.3), exhausted. Proceeded to get mild chills & headache 2-3 hours later. Headache, chills, aches continued to intensify as fever continued to climb (t-max 102.1). Took 600 mg of ibuprofen 32 hrs post vaccine. Woke up 4 hours later and headache was gone, fever broke. Continued to be chilled/achy/exhausted for up to 4 days post vaccine

Muscle pain across shoulders starting at 2pm after 9 am shot on 2/23. COVID arm, large red bump on arm, warm to touch and hot following morning, noticed at 7 am on 2/24. Under arm, armpit and down into rib area sore when arm is raised, noticed 7 am 2/24 pain gets worse throughout day. Pain in upper back across shoulders as well during day. All listed above is still ongoing at the same pain level.

Moderate pain and inflammation in left armpit area starting 12 hours after 2nd injection. Pain and sensitivity in area continued for 3 days. Also mild fatigue and general achy feeling for 2 days after shot.

Joint/muscle aches; Joint/muscle aches; Mild headache; Sneezing; Sniffling; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3248, expiration date was unknown), via an unspecified route of administration in the left arm on 27Jan2021 at 11:45 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the hospital. The patient had no medical history; she had no known allergies. Concomitant medication included escitalopram. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 28Jan2021 at 15:00, or around 30 hours post-vaccination, the patient experienced joint/muscle aches, mild headache, sneezing, and sniffling. The patient did not receive any treatment for the adverse events (AEs). The patient was not recovered from all the events.

6 hours after vaccine developed bilateral upper extremity numbness and weakness. R arm symptoms resolved in 30 minutes. L arm symptoms persist. Awoke with a headache 2/27/21 with headache-severe R sided temple. Had brief urinary urgency but did not urinate. L arm weakness and numbness persistent. Arm function returned but has persistent inability to move / use L hand and has loss of sensation L hand /forearm in glove distribution to mid forearm.

sore arm; diarrhea; sore rib; lump on neck; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: Ek4176), via an unspecified route of administration in the left arm on 12Jan2021 at 16:45 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, PCOS (polycystic ovaries), and allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination, and was not pregnant at the time of vaccination. Concomitant medications included levothyroxine, metformin, and daily multivitamins (also reported as medication that the patient received within two weeks of vaccination). After the first dose, on 15Jan2021, the patient experienced sore arm, diarrhea starting day 3 through today, sore rib, and lump on neck. It was unknown if the events were treated. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).

Immunization administered on 12/27/2020. On 01/04/2021 I began to break out in full body urticaria with facial edema and joint pain. Followed up with allergist and rheumatology. Both ruled out allergy or rheumatological causes. Elevated CRP of 116. Ongoing urticaria outbreak since onset.

Injection site pain, tiredness after 30 minutes, muscle pain in right arm, - joint pain, injection site swelling, nausea, and headache.

Severe swelling, tenderness, pain to touch in the lymph nodes on the left side of my body. From my neck, to my armpit, to my low back and in my groin, i have swelling in spots up and down my left side. I had a fever starting 24hr after the injection. This lasted until today and was treated with OTC IBUPROFEN. The ibuprofen has had no effect on the swelling or pain in nodes. Aches, chills, and joint pain are other secondary complaints/effects with more milder level of pain. It?s been 3 days since injection and the swelling in my lymph nodes does not seem to be getting better.

headache; 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2/fever; chills; muscle aches; nausea; This is a spontaneous report from a contactable Other Health Professional reported for herself (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302; expiration date not provided), intramuscular (left arm) on 02Feb2021 13:30 at SINGLE DOSE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Patient is not pregnant. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140; expiration date not provided), intramuscular (left arm) on 13Jan2021 for COVID-19 immunisation. The patient experienced headache, '9.5hrs after the 2nd vaccine dose a fever set in', chills, muscle aches, and nausea all on 02Feb2021 at 23:00. Patient's clinical course is as follows: 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2. To accompany the fever were chills, muscle aches, nausea, and a headache. After taking a fever reducer, the nausea stayed and the fever returned approximately 8hrs as did the chills, muscle aches, and headache. It was reported that patient took a fever reducer again and now waiting to see if that helps again. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included body temperature with result of '101.2 (9.5hrs after 2nd vaccine dose a fever set in, and climbed to 101.2)' on 02Feb2021. The patient has not received treatment for headache, chills, muscle aches, and nausea. Facility where the most recent COVID-19 vaccine was administered was reported as 'Workplace clinic'. Outcome of the events was not recovered.

sore neck; fatigue; Sore arm muscle at injection site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in arm left, on 18Feb2021 15:00, as single dose for COVID-19 immunization, at workplace clinic. Patient's medical history included Asthma, Herpes, Bipolar 2 Disorder. Patient had no Allergies to medications, food, or other products. Concomitant medications included valacyclovir, montelukast and lamotrigine (within two weeks of vaccination). Historical vaccine included first dose of BNT162B2 (lot number; unknown), via an unspecified route of administration, in Left arm, on 28Jan2021 3:00 PM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 18Feb2021 15:00, the patient experienced sore arm muscle at injection site after injection and continuing into second day (19Feb2021); sore neck and fatigue starting the next morning. Patient was not received treatment for adverse events. Seriousness of the events was reported as non-serious. Outcome of the events was recovering. Information on the lot/batch number has been requested.

About 36 hours after shot, my lymph nodes in my left arm pit became swollen and painful. This progressed to the lymph nodes around my chest and neck, and I developed a lump of swollen lymph nodes on the back of my neck about 48 hours after my shot that lasted about a day. My lymph nodes in my chest arm and underarm stayed swollen for about a week. About 48 hours after my shot, I began experience minor muscle spasms in my right foot, then in the arm muscle where I was injected. Throughout that day and the next week, I experienced minor muscle spasms throughout my entire body. They were most prominent on my left side of my body where I got the injection. I also felt weakness and tingling in my left arm for about a week. The muscle spasms throughout my body and weakness in my left arm continued slowly subsided over about 3 weeks after my shot. They were minor spasms, but were persistent across the three weeks.

The day after I had major chills, joint pains, nausea, really sore, extreme flu like symptoms. It was a miserable 24 hours, then after I felt like I had about 20 energy drinks and this lasted for about a week.

The muscle around the injection site was very stiff shortly after the injection. No pain to touch around injection site. On 3/6/21 I started experiencing slight pain in my axillary region. Pain was probably 3 of 10. Stayed at this pain level until 3/8, when it started to increase and to date pain is increasing and there is a large lump in my under my arm. Lifting my arm above my shoulder increases pain. Pain also wraps around to my shoulder area. I have never had any pain in or around this region until after the vaccine.

some kind of back pain, behind her heart; heart pain; pretty strong chest pain; fatigue caused by the vaccine was so profound; This is a spontaneous report received from a contactable consumer(reporting for her daughter) A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 expiry date 31Mar2021 via an unspecified route of administration on 08Jan2021 (at the age of 29-year-old) at single dose for COVID-19 immunisation. The first dose of bnt162b2 was taken on 17Dec2020. The patient's medical history included bipolar disorder. Concomitant medications included quetiapine (QUETIAPINE). The patient experienced some kind of back pain, behind her heart, heart pain and pretty strong chest pain on 08Jan2021 with outcome of recovered. In addition experienced "fatigue caused by the vaccine was so profound that was advised to not take her bipolar medication, quetiapine" on an unspecified date with outcome of recovered. It was reported that "It took 36 hours for the extreme fatigue to stop. This was very frightening because being without the medication could cause auditory hallucinations to return after 36 hours. There should be a warning for people who must take sedative medication regularly so that they can make an informed decision about whether or not to receive the vaccine".

Tingling starting in feet three days after vaccination, now w/ muscle spasm in back, feet and leg tingling and feeling of weakness in legs.

Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on left chest and shoulder with muscle pain. Left arm became numb, rash at injections site, migraine, numb lips and mouth. Persisted and progressed to vomiting and diarrhea, tachycardia and tachypnea. On 1/14, petechiae around both eyes, widespread muscle and joint pain, tachycardia and tachypnea persist, unable to lift left arm, itchy face, nose and throat. 1/15 Tachycardia persists, migraine, diarrhea, sudden onset vaginal bleeding. 1/16 elevated blood pressure, tachycardia and tachypnea, found unresponsive in bed by my husband and taken to the emergency room.

" Heart rate went up and my lips, tongue and throat started swelling"" I took 3 Benadryl and had taken Allegra that morning. It seemed to work and the swelling went down. Bad back pain, arm pain headache, general muscle aches, fatigue and my grip strength is very weak"

Onset within minutes: dizziness, confusion, and facial numbness in both cheeks, eyes, nose, jaw and muscle stiffness in the face which lasted until the following day. Following morning, there was sharp pain at the injection site and I was unable to lift my arm at all. In the evening I can lift it half way. Still experiencing 32 hours later: headache and brain fog and dissociated feeling, fatigue, and body aches. Neck remains stiff. Never had any adverse or allergic reaction to anything before and didn't become fully aware that something wasn't right until after I left the facility yesterday.

Fever of 101.3 across 24 hours, alternating chills and sweats, severe muscle and joint pain and discomfort, fatigue, nausea, loss of appetite.

Migraine; Nausea; joint pain/specifically in a joint that had a previous injury (not all joints).; This is a spontaneous report from a contactable consumer, the patient A 29-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 16Feb2021 at 13:15 (at the age of 29-years-old) as a single dose, for COVID-19 immunisation. Medical history included Osteoarthritis of the knee due to an injury, Known allergies to cats. No concomitant medications. Historical Vaccination includes BNT162B2 Dose 1, lot number=EL3247, administration date=26Jan2021 at 13:15 in the left arm for COVID 19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 03:00, The patient experienced Migraine, nausea, and joint pain specifically in a joint that had a previous injury (not all joints). No treatment was given for the events. The clinical outcome of the events migraine, nausea and joint pain was recovering. :

Patient reported some ankle swelling in the left leg the morning after vaccination. no other events were reported. on seeing the ankle it was visually a little larger than the right ankle. pt was not too worried and had already contacted PCP with photo, I advised a follow up with a PCP and to go to urgent care if it got any worse.

29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.

High fever, aches, chills, nausea, soreness at injection site, trouble sleeping, headaches, joint pain

About 30 minutes after my face got flush. It stayed flush, but no temperature on work gun 97.2. Woke up with fever 100.5, joint pain, headache, and little pain in the right side of my neck.

In the week following my vaccination, I presented no symptoms. After day 7, I developed soreness/tenderness in my left armpit and a series of neurological symptoms that are very concerning including depression, anxiety, insomnia (accompanied with heart racing, sweating, tingling in extremities, obsessive thoughts etc). Although, I have had sleep issues during the course of the pandemic, I do not deal with daily anxiety. I very rarely have to turn to any medication and especially have not had any anxiety symptoms or sleep issues recently. I do not believe the CDC has commented on the connection between vaccine safety and any relationship between vaccine immune response and neuropsychiatric disorders. Or how antibodies produced via vaccine react to other proteins. My daily activities have been significantly impacted over the course of this week. I would appreciate learning if there is possible cross-reactivity and if that has presented in other adults.

Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left deltoid, on 11Jan2021 09:55, at a single dose, for covid-19 immunization. The patient's medical history was not reported. The patient's father got thyroid storm from influenza vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscularly on the left deltoid on 20Dec2020 18:00 for covid-19 immunization at the age of 29-years-old and experienced L face; tongue, L upper; lower, extremity numbness. The vaccine was received at the hospital. The patient experienced numbness/blunted sensation in L whole upper lower extremity, L face, L tongue on 11Jan2021. As treatment, the patient received acetaminophen 650mg po on 11Jan2021. The patient then experienced feeling of weakness in L upper/lower extremity on 22Jan2021. All the adverse events resulted in a visit to an emergency room. The patient was admitted to the hospital due to all adverse events for 2 days, from 02Mar2021 to 04Mar2021. The patient underwent lab tests and procedures on 24Jan2021 which included the following: MRI brain w/wo con with results of negative, MRI spine w/wo con with results of negative, CT head wo con with results of negative, and CXR with results of negative. The patient underwent lab tests and procedures on 02Mar2021 which included the following: MRI head with results of negative, CBC with results of negative, MRI neck with results of negative, MRI brain w/wo con. with results of negative, CMP with results of negative, UDS with results of negative, U/A with results of negative, and B12 with results of negative. The patient underwent lab tests and procedures on 03Mar2021 which included the following: CSF with results of negative, TSH with results of negative, and PT/INR with results of negative. The patient underwent MRI spine w/wo con on 04Mar2021 with results of negative. The outcome of the events was unknown.; Sender's Comments: Causality cannot be excluded for the reported serious events and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

fever 99.9/ fever 100.6; chills; sweats; muscle aches; joint aches; fatigue; confusion; migraine; severe nausea; This is a spontaneous report from a non-contactable consumer (patient). This 29-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration on 15Feb2021 at 13:00 (at the age of 29-years old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccine. Concomitant medications included birth control; caffeine, paracetamol (EXCEDRIN), and ibuprofen from unknown dates for unknown indications. The patient previously received acetaminophen in doses over 500 mg and experienced allergy. On 16Feb2021 at 02:00, 13 hours after the vaccine, the patient experienced fever of 99.9, chills, and sweats. Sixteen to twenty-eight hours after the vaccine the patient experienced fever of 100.6, sweats, muscle aches, joint aches, fatigue, confusion, migraine, and severe nausea. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of fevers of 99.9 and 100.6, chills, sweats, muscle aches, joint aches, fatigue, confusion, migraine, and severe nausea were recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Outer hip pain, woke up with it on Friday March 19th (2.5 days after shot) lasted until Thursday March 25th Would be more painful at night and would go away with Tylenol. Started my menstrual period during this time and thought the pain could be from that until I heard of others having lower back and hip pain after the shot.

1:50 p.m. vaccine given. 9:30 p.m. began feeling feverish. Severe chills, sweating, and aching until 7:00 a.m. next day (3/26). 101 degree fever persisted from 7:00 a.m. to 4:00 p.m. on 3/26, decreased to 100.4 degrees in the evening of 3/26, aching continued all day on 3/26. Chills and sweating all night again, 3/26 to 3/27. Temperature decreased to 99.3 degrees on 3/27, but continued feeling achy. Large swollen and painful lymph node in left armpit from 7:00 a.m. on 3/26 to present.

Pain at injection site starting approx. 1 hour after injection and continuing yesterday and today (3/29/21), fever, chills, and headache starting approx. 3-4 hours after injection and lasting approx. 12 hours, joint pain in right knee and right elbow starting approx. 24 hours after injection and continuing today (3/29/21).

Patient described myalgias, headache and dyspnea at ER visit on 4/1/21 at 2:37 am. Patient was discharged. Patient returned the same day at 15:40 cyanotic, altered, hypoxic and hypotensive. The patient was found to have profound metabolic acidosis, liver failure, renal failure. She went into cardiopulmonary arrest, was revived, rearrested and died. Patient was treated for possible sepsis, shock, liver failure.

Everything started on January 24th at about 7pm exactly 20 days post first Pfizer vaccine. No other changes or vaccines given since October (flu vaccine) was scheduled for 1/25/21 for second Pfizer dose. It all started when I was working at ER when I started to feel cold like it was in an ice bath and numbness in both feet. I went to discharge my patients when I realized ascending numbness and coldness from the feet was traveling upward. Within 5 hours (around midnight) I went to hospital due to having severe weakness to where I couldn?t walk and loss of bladder control. I was rushed to MRI of brain, cervical, thoracic, and lumbar. I also had blood work done and a lumbar puncture. I was admitted for a couple days to watching the ascending weakness and loss of feeling. My MRIs came back clear from any diseases such as transverse myelitis, MS, etc. My LP showed mild elevated protein at 54 (normal range 15-45), one tube elevated lymphocytes 100% (range 40-80%) and one tube elevated monocytes 50% (range 15-45%). Also CK-MB w/reflex was 352 (range 26-140). I was discharged on 2/26 at 5:30pm with a diagnosis of bilateral leg weakness and numbness. From this point on I was wheelchair bound at home and being cared for 24/7. After discharge some additional random symptoms started such as chills with no fever to where I slept in sweat pants and sweat shirts, leg spasms/ twitches, leg heaviness, severe lower back and hip pain, a loss of sensation while going pee or poo but not incontinent, and things like drop foot with the severe weakness and numbness . On 2/3/22 I started with double vision, blurry vision and pain behind my right eye. I went to ER and had repeat MRIs of brain, cervical, thoracic and lumbar with and without contrast and basic blood work and was sent home to follow up with Dr. on 2/9 and was discharged home. By 2/8 my strength started to get worse to where I couldn?t lift my kids. Finally saw Dr. neurology and MS specialist 2/9, he ran detailed neuro exams from head to toe, looked at both scans from both hospitals, all the blood work and LP results. He reported that I had severe hyper reflexes in both legs and Hoffman?s sign in both hands. My feet were completely numb and cold to where I couldn?t feel them or walk. Literally felt like everyday I was standing in a ice cold bath with no feeling of touch hot or cold sensation or pin pricks. He realized my loss of sensation was from my bra line down and included tingling in my hands and weakness in my arms. I was able to get up for the first time with a walker and take a few steps with assistance at this time. He then sent me to ER to be admitted and see their neuromuscular team to get further treatment. Upon arrival via wheelchair I was brought back to see the ER Doctor and re-did a neuro exam, some blood work and contacted the neurology team to come see me. I was then admitted to the hospital step down ICU under Dr with strict monitoring. On 2/10/21 The neuro team ordered another set of MRI of brain, cervical and thoracic with and without contrast due to a change in condition again since my last visit to hospital. They reviewed and compared studies with no changes. They scheduled me for MRI lumbar on 2/11/21 with and without contrast which came back no changes from previous MRI as well as another LP which everything that was off before was now normal. Everyday I would work with PT, OT and speech. I had no changes in speech and slowly got some strength back, and was able walk using a walker. I was then discharged home on 2/13 mid afternoon and was told I would do home health and follow up with their neurologist and Neuromusclar team once everything was resulted back. On 2/19/21 I saw my primary doctors office (nurse practitioner) where she checked up on the status of me, took me officially off work and on state disability, filled out paperwork for work and a handicapped pass. On 2/25/21 followed up with neurology, and discussed all my imaging and blood work. All CSF fluid came back normal, all labs were fine and wanted me to get an EMG to look for nerve damage. She also wanted a follow up with cardiology as my resting heart rate was 110-120 and would spike to 160s. On 3/1/21 Home health was started for physical therapy for strengthening and working on sensation for both legs. At this point I had almost full strength in my arms, still tingling in my hands and constant numbness and cold feeling in both feet and knees with severe sensitivity to cold, wind or touch on my legs. I had Home health twice a week every week for 2-3 weeks then started outpatient physical therapy which has been twice a week for 1.5 hours. On 3/5 I saw cardiology and was placed on a holt monitor for 48 hour monitoring. On 3/9 I had my EMG with Dr. and had a follow up with Dr. for 35 tubes of blood he had drawn for multiple diseases which both blood work and EMG came back negative. On 3/16 symptoms started to change from numbness to severe hypersensitivity to touch, severe shooting nerve pains, burning sensations, non stop tingling in hands, issues with temperatures either hot or cold, and swelling of both legs. On 3/17 I saw rheumatology that looked into everything said it was not lupus related as none of my inflammatory markers or lupus DNA strands were elevated and no lupus symptoms like rashes, ulcers in the mouth or tongue, hair loss or joint pain. He ordered more blood work and confirmed it was not a lupus flare up. He suggested doing a small nerve fiber biopsies. On 3/19/21 saw spinal orthopedics who reassured it has nothing to do with my spine, prescribed gabapentin for all the nerve pain and told me that neurology is who should be following me. On 3/26 I had an echocardiogram done due to the leg swelling and heart rates which came back negative for any heart problems and was told since the tachycardia is getting better to just continue watching it and was prescribed trazodone 25mg to help with sleep due to severe nerve pains, spasms and severe back and hip pains at night. On 4/1/21 was followed up again with neurology. Ordered small nerve fiber biopsy for may 18th, increased the gabapentin to 300 mg- 3 times a day and had me wean off cymbalta. I am still dealing with tingling, burning hot and cold sensitivities in both legs, still tingling in hands all day but strength is back to full. I am scheduled to hopefully return to work 5/30/2021 after being off since 1/24/2021.

passed out from exhaustion; Fever; was unable to stand unassisted.; writhing in pain/so much pain; in and out of consciousness/passed out; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; sweating profusely; couldn't support her own body without tipping over.; seizure; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; chills; extreme muscle pain; spasms; This is a spontaneous report from a non-contactable consumer (patient herself). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 13:15 (Batch/Lot Number: ER8737) as single dose, for COVID-19 immunisation. Medical history was reported as no. Patient did not have COVID-19 prior to vaccination. Patient did not receive other vaccines within 4 weeks prior to COVID-19 vaccine. Patient's concomitant medication includes omeprazole, ethinylestradiol, levonorgestrel (MARLISSA), venlafaxine and gabapentin from unspecified dates, received within 2 weeks of vaccination, for unspecified indication. Patient historically took first dose of Pfizer BNT162B2 (Lot number: EN6204) on 13Mar2021 at 11:00 AM on the left arm for COVID-19 immunisation. Patient previously took hydrocodone bitartrate, paracetamol (VICODIN) on an unspecified date and indication and had allergy. On 02Apr2021, around 10pm, patient began having chills and extreme muscle pain and spasms, and the lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain. By midnight (03Apr2021 00:00), patient had a fever and was unable to stand unassisted. She was writhing in pain and arching uncontrollably off the bed. She believed in hindsight that this was a seizure as she went in and out of consciousness and her tongue swelled up, making it hard to breathe and impossible to speak. She was sweating profusely, and had to drink water constantly. Her husband had to help her get to the bathroom because she couldn't support her own body without tipping over. The chills and fever alternated all night, and she finally passed out from exhaustion at 03Apr2021 at 7am. The next 2 days, she was in a cycle of fever and chills again, and the fever got so bad that she seized twice more on Saturday (03Apr2021). She had to take the day off work on Monday (05Apr2021) as she was still in so much pain that she could barely leave bed except to use the bathroom. Events were reported as life-threatening, immediate risk of death from the events. Patient was not hospitalized. Treatment for the adverse events were cool baths, naproxen (ALEVE) for fever and pain, and PEDIALYTE. COVID-19 was not tested post vaccination. Vaccination facility type was at a hospital. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Nausea; Pain in legs, back and arms; Pain in legs, back and arms; Headache; Low blood pressure; pregnant at the time of vaccination; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 at 14:30 at single dose for COVID-19 immunization. The relevant medical history was reported as none. Concomitant medications were not reported. The patient experienced nausea, pain in legs, back and arms, headache, low blood pressure on an unspecified date. The patient was pregnant at the time of vaccination. The patient last menstrual period was 15Nov2020. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

This is a spontaneous report from a contactable physician. A 29-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history was not reported. The reporter is not related to a study or program. Concomitant medications included unspecified medication (She does take other medications but does not know the significance). On 30Mar2021, the physician stated that, the patient developed immediate right-side neck pressure, skin and jaw tingling, and swollen lymph nodes. She did not have any trouble breathing and did not have any hives. These events were considered as medically significant. The pharmacist gave her 2 Benadryl and she stayed there for an hour. She said she does not think the Benadryl did anything for her. The physician stated that the patient went home and slept off the immediate reaction she experienced and had fatigue for 3 days. The patient had fatigue for 3 days and no other problems. The physician inquired on advisable information for the second dose. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Extreme numbness in hands that is worsening over time. Causes extreme pins/needles, aching and inability to hold basic objects like a cell phone. Attempting to see a doctor for this immediately. Originally had this in December -- presumably with COVID that never got diagnosed. Worsened after 1st shot, worsened dramatically after 2nd shot.

Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received BNT162B2 for COVID-19 immunization on 31Mar2021 (Lot unknown=True, Lot unknown reason=Unable to locate or read the details, Administration date=31Mar2021, Administration time=02:00 PM, Dose number=1, Vaccine location=Left arm, No reaction.) On 24Apr2021, Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs. The patient did not receive treatment for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermittent 1500- chest tightness, palpitations lasting 20-30 minutes 1900- feet b/l ice cold, muscle aches, chills, lasting 8 hrs 12/29/2020- upon awakening-fatigue, SOB 6 hrs, intermittent paresthesia persist left foot, left cheek, new onset teeth pain (lasts less than 1 minute) left sided headache (1-5 min) left sided back pain at SI joint 12/30- tingling sensation persist, fatigue is gone. Chills- 1-3 min duartion, intermittent. left ear pain, left headache, "pings " of left cheek, tingling back pain persists (left) 12/31/2020 noted mild left facial weakness-, left eye brow rise, unilateral wrinkle forehead, smile reduced left sided tingling persists with intermittent headache, ear pain, teeth pain sought care of PCP tx of early onset bells palsy with steroid taper + PPI Began prednisone 40 mg PO 1/1/2021 left sided back pain persists

100 degree fever, body aches, sore under arm/armpit of left arm (injection arm), fatigue, nausea, slight headache, swollen lymphnodes

Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain and shortness of breath in which EMS was called and I was taken to the hospital. Since then, I lost feeling in my hands and feet, numbness and tingling. I've improved however, during my recovery suffered with spinal pain, shortness of breath, very winded, muscle pain and loss of appetite to especially meat.

Become tired after returning home from getting the vaccine. I fell asleep and woke up to large hives on my face. Not much longer and the hives/itching spread down my back and chest. Face became swollen. Benadryl cream was initially attempted, but only briefly subsided the itching and reaction continued spreading. I took oral quick release Benadryl and was able to prevent the reaction from continuing. I had to take a secondary Benadryl dose a few hours later and extreme joint pain accompanied the allergic reaction.

Pfizer-BioNTech COVID-19 Vaccine: On the day I received the first does of the vaccine, I felt fine until about 6 hours later. At that point, I started to get very dizzy and lightheaded. Every time I opened my eyes, everything was spinning. This lasted four about 3-4 hours. I kept breaking out into sweats. I had a horrible headache for about 4 days straight. I am still continuing to having headaches. I am still having hot flashes and dizziness episodes at times that go away after about a few minutes. Two days ago, I stated to developing swelling in my hands with achy joints which has not gone away.

For 2 days after the vaccinations, my left deltoid/ upper arm was sore. Approximately 7-8 days after my vaccination, my left armpit started feeling sore. This has continued to today where I have left armpit swelling and what feels to be a swollen, hardened lymph node in my armpit. It feels like a hardened lump that is not fixed and is tender when I palpate it. On visual inspection, I can tell that my left armpit is more swollen than my right armpit (which is normal). It hurts to have my arm at my side and it hurts to lay on my left side at night when I am sleeping.

Initially soreness in injection area; body backs with back, hip, and knee pain limiting mobility; body backs with back, hip, and knee pain limiting mobility; limiting mobility; Fatigue; chills; This is a spontaneous report from a contactable Other HCP (patient). A 30-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration in right arm, on 28Dec2020 03:30 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Relevant medical history included COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. The patient experienced Initially soreness in injection area on 29Dec2020 10:30 AM. At 19 hours after vaccination started to experience body backs with back, hip, and knee pain limiting mobility on 29Dec2020 10:30 AM. Fatigue and chills fan at 24 hour mark and are continuing now at 28 hours on 29Dec2020 10:30 AM. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

12 hours after injection I began to have chills and rigors, the rigors subsided after ~30 min. For the next 11 hours i had chills, severe body aches, a headache and spiked a fever to 101. The following day after ~12 hrs of symptoms I began to improve slightly and all that remained was a severe headache and body aches. Now, I am about 32 hours in to the adverse event and I still have a headache and sore arm/shoulders but other symptoms have resolved.

Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; This is a spontaneous report from a contactable Other Health Professional for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685) dose number 1, intramuscularly on 26Dec2020 15:30 at single dose on arm Left for COVID-19 immunization. Medical history included irritable bowel syndrome, chicken allergy and COVID-19. Concomitant medications received within 2 weeks of vaccination included clonazepam, spironolactone and melatonin, all from unknown date for unknown indication. Onset of symptoms began roughly 9hrs post vaccine. Lasted roughly 24 hours (28Dec2020). Body aches, low grade fever, chills, shivering, headache, nausea, stiff/sore arm. Adverse event start date: 27Dec2020 00:00. No treatment was received for the events. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was resolved on 28Dec2020.

Fatigue; Muscle soreness in the arms, neck, and upper back; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on left arm on 16Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included obstructed sleep apnea, chronic sinusitis, and obesity. The patient has no known allergies. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at a hospital and the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experience muscle soreness in the arms, neck, and upper back as well as fatigue on 17Dec2020 12:00 (starting about 24 hours after the vaccination). The symptoms were resolved by the next day (Dec2020), or approximately 48 hours after the vaccination. No treatment was given for the events. Information about lot/batch has been requested.

When vaccine was administered, seemed high on my arm. I had immediate soreness and shoulder discomfort, I was told this was normal. It continued to progress and I eventually had decreased ROM, weakness and sharp shooting pain in my shoulder. Working at OI, I consulted provider, xrays were obtained and I was evaluated. He strongly suggested an MRI be obtained as well. That was completed the same day as my evaluation on 12/31/2020 (1 week and 2 days after the vaccine was administered). The provider informed me that they have had patients with similar situations that were evaluated for frozen shoulder after having a vaccine d/t administration site and vaccine going into subacromial space. He does report that this was my case/situation, upon my exam, I had severe inflammation with this as well-he is now having me follow up for a surgical consultation for my shoulder to be repaired. Today's date is 1/7/2021, I have these same ongoing symptoms that have continued since day of administration, without diminishing in severity. He is unable to provide an injection d/t my upcoming second dose of the COVID vaccine this next week, 1/12/2021. He strongly suggests that my 2nd vaccine be administered elsewhere-advised NOT be administered in the same shoulder OR in opposite to cause these symptoms to flare. He advised in gluteus if possible to avoid any further issues if at all possible.

5 days after injection started a light headache. 6 days after injection joint pain, in hips and tailbone. feeling fatigue, nausea. with decreased appetite. Night time of day 6 stomach cramps with diarrhea.

Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination. Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.

Chills, myalgias, rash to chest and ear that is pruritic (started day after the vaccine and continued to day 3 post vaccine). No signs of anaphylaxis.

Headache back of neck, twmples and eyebrows, really sore injection site. Fatigue, Malase, nausea off and on, decreased appetite. Feeling dehydrated, chills/ at times painful sensitive skin similar to the flu. Muscle aches throughout the body.

Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next morning I had a fever and my joints, muscles, head and even my skin was hurting. My fever never came down to normal even with advil and I was extremely tired all day. The arm that had the injection is extremely sore with splotches of red (which is expected.) Today, 01/08, I woke up in a pool of sweat. My head is still hurting and I still have a fever. My arm is still sore but my skin and joint pain has improved. I am still very cold. Have been wearing my winter coat in my house even with the heat and the fire place on. I had to take the last two days off work.

left deltoid was sore; left armpit was sore; It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest; left armpit is noticeably more swollen than right armpit; swollen, hard, lymph node which is not fixed when I palpate it; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 22Dec2020 at 12:00 at the age of 30 years at single dose for COVID-19 immunisation. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks and she did not receive other medications in two weeks. Relevant medical history included allergy to sulfa based medication. Concomitant medications were none. On 29Dec2020 at 17:00, the patient experienced left deltoid was sore, left armpit was sore, soreness was radiating down her left side and into her left chest, left armpit was noticeably more swollen than right armpit and swollen, hard, lymph node which was not fixed when she palpated it. The patient reported that for 2 days after the vaccination her left deltoid was sore which went away. Then, approximately 7-8 days after the vaccination, she noticed her left armpit was sore. This has persisted and the patient could feel a swollen, hard, lymph node which was not fixed when she palpated it. Her left armpit was noticeably more swollen than her right armpit (which wass normal appearing). It was sore to have left arm on side and it was sore when she layed on her left side to sleep. Soreness was radiating down her left side and into her left chest. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient did not receive corrective treatments for the reported events. At the time of the report, she had not recovered from the events. The information on the lot/batch number has been requested.

Soreness at the site about 3 hours after the injection followed by headache about 24 hours after. Then about 48 hours after, developed diffuse myalgia and drowsiness

light headed, sore throat, swollen throat, body and muscle aches and fatigue, encouraged to seek medical attention.

Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on left arm on 02Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included fibromyalgia. The patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced low grade fever, tingling face and tongue, muscle aches, and fatigue, all on 03Jan2021 06:00. The events were reported as non-serious. Patient was not diagnosed with COVID-19 and has not been tested for COVID-19 prior to vaccination. Outcome of the events was recovering. Information on the Lot/Batch Number has been requested.

severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints and muscles, headache, achy eyes, extreme tiredness, itchy all over and swollen, painful and itchy injection site.

Neck pain, chills, high fever, joint pain for 72hrs nausea, abd. cramping (48 hrs post vaccine) persistent symptoms lasting 5 days after COVID vaccine Cervical & submandibular lymph adenopathy

Full day on 01/09/21-extremely sore muscles to the point of it being painful to move and breath. Extremely painful joints. Felt like there was an ice pick trying to pry them apart. Full day 01/10/21-hives and extremely itchy. Sore, not as bad as first day.

The day after I received the second dose, I experienced arthralgia, chills, fever, and muscle aches. The second day after the vaccine, those symptoms were much relieved.

At 8 am on Friday morning, about 14 hours after I received my 2nd dose of Pfizer covid vaccine, I had muscle soreness and aching. I went home and slept after working night shift. I woke up at 11 am, 17 hours post vaccine, and had a 102.4 F fever, chills, body aches and headache. At 3pm I still had 102-103F fever and called employee health and in which was directed to take Tylenol or Advil. I took 600mg Advil, and my fever broke at 8 pm, 26 hours post vaccine. That night my fever returned 102-103 F, I continued to take Advil. I took Advil around the clock, but let it lapse in dose Saturday evening 50 hours after receiving my vaccine. I then had a 101.5 F temp, I waited and it continued to rise, at midnight tonight, 30 mins ago, I took 600 mg Advil

About 12 hours of receiving my second dose I started to get really bad chills. Nothing could keep me warm and I had a fever of 102. I had muscle aches as if I just went through a rigorous workout. I had zero appetite but I?m not sure if that was due to side effects or the fact that I wasn?t feeling well. When I did finally eat something that evening I could barely taste it, I ate it but my taste buds were faintly picking up the flavors. Again I don?t know if it was because of the side effects or the fact that I wasn?t feeling well. The following day, Saturday 01/09/21 I only had chills which would come and go. I did not have fever and my appetite was back. Now today, 01/10/21 I feel my usual self.

Fatigue, muscle aches, joint paint, slight headache beginning early morning on 1/9/2021. Chest pain from 9pm 1/9/2021 to 2am on 1/10/2021. Symptoms resolved without any interventions.

Strong pain throughout my body. Stronger pain in lower back and neck. Fatigue and tiredness. Stomach malaise

Slight pain at the injection site; sore/tender muscles on the left side of the body (mainly shoulder & neck); soreness/stiffness in left hip; soreness/stiffness in left hip; fatigue; This is a spontaneous report from a contactable pharmacist, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1284) solution for injection intramuscular in the left arm on 31Dec2020 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01Jan2021, the patient experienced slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. No treatment was provided for the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. The outcome of the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.

Pain at injection site, constant, began ~2 hours after vaccine administration-time of VAERS submission Chills, duration from 3 AM-5 AM on 1/11/2020 ~14 hours after vaccine administration Generalized muscle aches, constant, began at 6 AM on 1/11/2020 - time of VAERS submission, ~ 17 hours after vaccine administration

At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they were on fire. The next morning I had chills, severe joint pain, fatigue, dizziness, nausea, and rash/ redness on my face (cheeks, nose, forehead). The next day (Sunday, the 10th) I felt much better but still a bit of joint pain and fatigue. Today (Monday the 11th) I felt fatigued, with. A resting heart rate of 90 according to my fitbit. I had some numbness/tingling in my right arm, dizziness, and felt fatigued. Towards the end of today I felt better but still have some pain in lower back and neck.

Fever, body aches, chills, joint pain, headache, felling inwell, fatigued, sore arm all started 12/28/2020 at 2100. Took cold/flu medicine

Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the Pfizer Covid vaccine yesterday (04Jan2021); back pain/back pain was pretty severe and was worse than it would normally be; severe headache that turned into a migraine; severe headache that turned into a migraine; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021) intramuscular at left deltoid on 04Jan2021 16:00 at single dose for covid-19 immunisation. 1st dose Pfizer covid vaccine was administered on 17Dec2020 (Lot number: EH9899). She was covid positive the day after receiving her first dose of the Pfizer covid vaccine. Her primary care informed her to get the booster despite testing positive for the virus. She was told since she was asymptomatic that she could get the vaccine. Medical history included back pain, covid from 3 weeks ago (Dec2020). There were no concomitant medications. The patient experienced back pain and severe headache that turned into a migraine on 04Jan2021, nausea and feeling unwell on 05Jan2021. She got the second shot of the Pfizer Covid vaccine yesterday (04Jan2021) around 16:00. Overnight she had back pain, severe headache that turned into a migraine. Now she had developed nausea and was generally feeling unwell. She had covid 3 weeks ago and she was instructed to get the vaccine. She has a history of back pain but states it was obviously triggered. Reports that last night her back pain was pretty severe and was worse than it would normally be. Nausea and feeling unwell was reported as worsened. Back pain was slightly improved. Headache that turned into migraine improved with medication. The outcome of events back pain and severe headache that turned into a migraine was recovering; of events nausea and feeling unwell was not recovered.

12 hours after vaccination: Uncontrollable Rigors, muscle contractions, fever, chills, hyperesthesia, abdominal pain, nausea, headache, back pain

aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a spontaneous report from a contactable Other HCP (patient). This 30-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK5730) intramuscular at left arm on 03Jan2021 at 10:30 AM at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications included cyclobenzaprine, levothyroxine and drospirenone/ethinylestradiol (NIKKI). The patient experienced aches and chills, headache and tight muscles on 03Jan2021 at 13:00. Then the patient had hot flashes and soreness in left arm from 03Jan2021 next 2 days. No treatment was received. The patient had no allergies to medications, food, or other products. The patient was no pregnant. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of all events was recovered.

Approximately 15 hours after vaccine, developed muscle aches, chills., elevated Temperature to 99.2 F. No true fever. Muscle aches, fatigue, and chills persisted for approximately 24 hours. All moderate intensity and with some response to tylenol/advil as needed. At 40 hours post vaccine, no remaining symptoms

Rigors; Feverish (yet afebrile); Myalgias; Fatigue; This is a spontaneous report from a non-contactable consumer (patient herself). This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose; and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at single dose, for COVID-19 immunisation. Vaccine location was right arm. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. On unknown date, the patient developed rigors, feverish (yet afebrile), myalgias, and fatigue. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the events. She recovered from the events on unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

The initial shot wasn't bad. Sore arm within 5 hours. That's all I had, until Thursday evening at 6. Overwhelmed with exhaustion and fatigue. Massive headache coinciding. My arm felt like I had tennis elbow and overall joint pain. Nausea and vomiting through the night. Went to bed about 9:30. Woke up with a fever of 99. Off and on fever and chills through Friday, 72 hours after initial injection. Finally resolved late Friday night.

Chills, body aches, joint pain, fatigue, dizziness. I took ibuprofen 400mg q6 with minimal effect. I felt much better by my second day after the vaccine but still with fatigue, dizziness and joint pain. By the third day after I felt back to normal.

I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the first time so quickly. It shortly progressed to a cold/numb sensation from my deltoid down to my finger tips. This persisted but seemed to transition from more numbness to moderate pain from my left scapula, neck and down to my fingers about 7 hours after the vaccine. I also developed intermittent fasiculations of my forearm muscles on the left arm. This morning I woke up with worsening pain, mild numbness but new weakness in the hand and arm. I have a weak grip and can?t fully grab objects. My wrist flexión and extension are also weak as well as shoulder abduction (I am a neurologist by the way so can?t localize it to any nerve distribution). I?m not weak anywhere else and I only have mild arthralgia and diarrhea systemically.

Joint pain and headaches. Also full body raised bumps (non pruritic, non pustular). Headaches resolved in about 1 week, joint pain and bumps have lasted a couple weeks now.

Adverse event contacted by V-safe was that I was unable to perform my job duties the day after the vaccine. Symptoms included left arm pain, back pain, aches/chills starting at midnight on 1/6/21 into 1/7/21. Headache lasted all day, slept intermittently all day, low energy and extreme fatigue. Was 13 weeks pregnant at the time of the vaccine.

15 weeks pregnant, due date 7/4/21. Fourth pregnancies one two year old, two miscarriage's. My left arm became super tender, I woke up with significant joint pain in my right knee. I almost couldn't walk, it was chronic pain when I tried to walk. It lasted about 24 hours and went away. I did inform my OB.

Myalgia; overwhelming fatigue; injection site pain and swelling; injection site pain and swelling; This is a spontaneous report from a contactable physician, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek4176, via an unspecified route of administration on 08Jan2021 at 08:30 (at the age of 30 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included attention deficit hyperactivity disorder, gastritis, and hiatal hernia all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included spironolactone, ethinylestradiol, norgestimate (SPRINTEC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), and 'dexylan', all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, lot number: Eh9899 on 18Dec2020 at 10:00 AM in the right arm. The vaccine was given at a Public Health Clinic. On 09Jan2021 at 12:00AM, the patient experienced myalgia, overwhelming fatigue, injection site pain and swelling. The patient did not receive treatment for the events. The clinical outcome of myalgia, overwhelming fatigue, injection site pain and swelling was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Neck stiffness/left jaw pain and stiffness within 1 hour of administion, lasting all day. Around 2100 the same night, rapidly progressing paresthesia of complete left face without obvious facial palsy yet (numbness happened over the course of about 30min to the point where I had no perception of touch in the left face). At this point I took 60mg of prednisone and went to bed. When I woke up, the paresthesia/stiffness was less and progressively so since finishing a course of prednisone. Concerned that this could have been a bells palsy reaction to the vaccine.

Immediately after the vaccine, my arm started burning in my neck and opposite arm joints became very sore throughout the day my entire body became extremely sore and I developed an ear ache and a headache and I am very fatigued. Today is the 17th of the month and that your aching headache still has not always go away. I?m not sure if this is a normal reaction or not.

Employee received 2nd dose of Pfizer vaccine. Approximately 24 hours hour had onset of fatigue, headache, muscle/joint aches. Interfered with normal daily activities. Lasted approximately 15 hours. Reporting per leadership guidance.

injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering took 1 Tylenol at 2:15 am. woke up at 3:23 am to bout of SVT 154 and tachycardia for a few hours after.

fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; Started having chills; Severe headache; collapsed on the way back to bathroom and was unable to get up for about 20 minutes; tachycardia; extremely fatigued entire day; This is a spontaneous report from a contactable Pharmacist who reported for herself. A 30-year-old female patient received her second dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number Ej1685) at a single dose at 09:45 AM 07Jan2021 at left arm for Covid-19 immunization in a hospital. The patient had her first dose of Pifzer Covid-19 vaccine on 21Dec2020 at 12:00 PM at left arm, and experienced very mild reactions which included mild pain at injection site and runny nose/sneezing day after vaccine. The paitent had a medical hisotry of rash to penicillin as a child. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to her first dose of Pfizer COVID vaccine. In the evening of second vaccine (around 17:00), pain and stiffness radiated from injection site all the way down arm, into breast, and middle of back. She started having chills. Around 10 hours after dose chills became somewhat violent despite being under 4 blankets. Severe headache also started. In the middle of the night to go to bathroom, she collapsed on the way back and was unable to get up for about 20 minutes. She also suffered from tachycardia overnight. her baseline heart rate runs in 60s- 70s, but was in 110s-120s (based on Apple Watch monitoring). Day after vaccine, she was extremely fatigue entire day and spent all but a few hours in bed. Arm pain mostly gone. Headache was very strong and persistent through the day. On second night chills not as bad but still occurred overnight. HR still elevated in 80s overnight. Morning of day 2 still had headache and fatigue. The patient did not receive any treatment for the events. The outcome of collapse and unable to get up for 20minutes, pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back was resolved, chills and tachycardia was resolving, headache, fatigue was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered that the events was non-serious.; Sender's Comments: Based on a chronological temporal association and known BNT162B2 vaccine safety profile, causality between events fainting, violent chills and severe headache and BNT162B2 ((Pfizer/ BioNTech Covid-19 vaccine) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Started with alternating chills and sweating at 10pm day of vaccine which lasted through the night. Never had a fever. Woke up the next day with a headache and significant muscle/body aches that lasted the day and into the night. On the 2nd day post vaccine still fatigued and new sore throat.

not feeling good (felt like crap); dizziness (really dizzy); weakness; shortness of breath (short of breath); arm feeling weak (arm felt weak); This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140, expiration date 31Mar2021) via an unspecified route of administration on 08Jan2021 at a single dose in the left arm as Covid-19 vaccine due to being a front line worker. Medical history included ongoing pre-diabetic from 2015. There were no concomitant medications. The patient received the vaccine today on 08Jan2021. Within 15 minutes (also reported as 15 minutes after the vaccine), she experienced not feeling good (felt like crap), dizziness (really dizzy), weakness, shortness of breath (short of breath), and arm feeling weak (arm felt weak) on the side where the injection was received. It's the weirdest thing, she never had issues with vaccines before. She was asking if this was normal. The outcome of the events was unknown. The nurse reported that the events were related to the suspect product.

Chills; fatigue; generalized muscle pain; back pain; pain in the arm injected; This is a spontaneous report from a non-contactable nurse. A 30-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number: EK9321), intramuscular om the right arm, on 04Jan2021 at 16:00, single dose for COVID-19 vaccination. Medical history included allergies to mango and swiss chard. Patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient experienced chills, fatigue, generalized muscle pain, back pain, pain in the arm injected from 05Jan2021 at 01:00. Facility where the most recent COVID-19 vaccine was administered was in a hospital. No treatment was reported for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021. No follow-up attempts are possible. No further information is expected.

chills and rigor; fever/febrile; headache; nausea; whole body muscle aches; This is a spontaneous report from a non-contactable nurse (patient). A 30-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ej1686), via an unspecified route of administration on 10Jan2021 10:30 AM at single dose on the left arm for COVID-19 immunisation. The patient is not pregnant at the of report. COVID-19 vaccine was administered in the hospital. Medical history included migraine, Polycystic ovarian syndrome (Pcos), seasonal allergies, penicillin and sulfa antibiotics allergies. Concomitant medications (Other medications in two weeks) included levothyroxine sodium (SYNTHROID), spironolactone, montelukast sodium (SINGULAIR), loratadine (CLARITIN [LORATADINE]) and calcium levomefolate (DEPLIN). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ej1685) on 21Dec2020 03:15 PM on the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient reported that on 11Jan2021 12:00 AM, 14 hours post receiving the second dose, she had chills and rigor and ended up with a fever. Patient took Tylenol, fever broke and 4 hours later again had chills and rigor febrile again and took ibuprofen. The patient also had headache, nausea, and whole body muscle aches. The events were assessed as non-serious. Outcome of the events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.

12 hours later - chills, fever, body aches; headache; joint aches; fatigue. Called Urgent Care and they had me take- Imotrix that I already had and tylenol and hydrated - lasted 36 hours. Symptoms resolved.

About 12 hours after - chills, fever , headache, body aches, joint ache (like flu) - lasted 36 hours. I hydrated - Took Imitrex that I still had; Tylenol and was back to normal after 36 hours. Called Urgent Care

Arm soreness started evening on 1/20/21. At 1:30AM 1/21/2021 I woke with a fever, chills, muscle pain, joint pain, muscle cramps, headache, nausea and fatigue. Highest fever 102.3, fever holding at 100.5 with Tylenol. Drinking fluids.

2200 - headache 2230 - headache worsens, nausea 2300 - headache + vomiting + chills, afebrile 2330 - Tylenol 1000mg 0100 - woke up with body aches, chills, headache 0300 - body aches worsen, nausea returns 0730 - body aches, armpits very tender, headache 0800 - Tylenol 1000 mg 0900-2200 fatigue, body aches, armpits tender, neck tender, headache 2200 - Tylenol 500mg, sleep 0500 - minor joint pain, minor armpit pain 0600 - Tylenol 500mg 0600-2200 - pain resolves

Rash on her right forearm consisting of clusters of vesicles on an erythematous base; rash is consistent with a diagnosis of herpes zoster or shingles; Radiating burning pain down the underside or volar side of her right arm to her wrist; first felt like a bruise; Radiating burning pain down the underside or volar side of her right arm to her wrist; first felt like a bruise; Pain then began to feel more like a bad sunburn with her skin being tender in the same distribution; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in right arm, on 04Jan2021 at 18:15, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was her workplace clinic. On 05Jan2021 at 03:00 PM, the patient developed radiating burning pain down the underside or volar side of her right arm to her wrist (vaccinated arm) that at first felt like a bruise within 24 hours of receiving the vaccine. In Jan2021, the pain then began to feel more like a bad sunburn with her skin being tender in the same distribution. Then on 11Jan2021, the patient developed a rash on her right forearm consisting of clusters of vesicles on an erythematous base. The patient consulted with a dermatologist in her primary care physician who agreed that the rash is consistent with a diagnosis of herpes zoster or shingles. This resulted in doctor or other healthcare professional office or clinic visit. Treatment received for shingles included valacyclovir. Post-vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.

I received the vaccine at 8:00am, and at approximately 7:00pm the same day, I developed a headache. About an hour later, I developed generalized muscle aches and subjective fever/chills. The symptoms did not interfere with my sleep, and when I woke up the next morning, the fever/chills had resolved. The myalgia and headache resolved by approximately 11:00am the day after I received the vaccine. I also had arm soreness from approximately 12 hours to about 72 hours after the vaccine.

Nausea; Muscle aches; General unwell; Anxiety; Body feels heavy and hard to move; Body feels heavy and hard to move; Arm where injected is very uncomfortable; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 12Jan2021 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Zk5730), via an unspecified route of administration on 22Dec2020 at a single dose on left arm for COVID-19 immunization (at 29 years old). The patient experienced nausea, Muscle aches, General unwell, Anxiety, Body feels heavy and hard to move around, Arm where injected is very uncomfortable on 13Jan2021 01:30 AM. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Severe body aches especially neck and back pain, nausea/vomiting, severe headache unrelieved by over-the-counter medication, light sensitivity, fatigue, severe injection-site pain, chills with low-grade fever (99.8F). Symptoms listed began approximately 18 hours after 2nd COVID-19 vaccine was given and lasted until 48 hours after vaccine was administered.

Received shot at 0610. Started feeling cruddy around 1600 w/ severe headache, neck pain, and shoulder pain, with overall malaise. Symptoms intensified at 2000 with severe rigors until ~0400 accompanied by body aches. Intermittent fevers experienced during that time as well. Next day, general malaise and severe body aches until ~1500; then subsided to mild headache and mild malaise. Post vaccine day #2 left with mild malaise, all other symptoms subsided.

extremely decreased blood flow (temperature) in extremities. Core far above normal temperature ( normally 96.8, currently 100.8). Sweating. Shaking due to cold extremities. Migraine. Pain in lower back (kidney area), chronic and achey. Joint pain in legs/ hips. Nausea constantly. Feeling of overall pain and discomfort. exhaustion.

Muscle pain on upper extemedies Hip,back , pain on both arms Left had has been swollen for 2 days After one week of vaccination

Felt chills, myalgia, malaise, nausea, GI disturbances in intestines (rumbling), bad headache (these have all lasted for about 24 hours so far

Burning of arm at time of injection, pain at injection site starting 3 hours post injection and lasting for 3 days, fatigue for 3 days, chills/fever for 3 days, myalgia for 3 days.

Within 30 minutes of injection, headache occurred that lasted approx 6 hours reported that was similar to first injection. Approx 2 hours after administration mild nausea that lasted approx 3 hours. At approx 16 hours after injection, headache again reported with elevated HR (approx 20 bpm above normal resting average), nausea, and muscle aches that lasted approx 3 hours. 24 hours after injection, low grade fever with muscle aches, chills, headache, and nasal congestion that lasted approx 5 hrs.

On the evening and day following receiving the second dose of the Pfizer vaccine, I experienced chills, body muscle aches, headache, and fever (99.7-100.2 degrees). I was unable to get out of bed or go to work. I took ibuprofen at first, for my muscle pain but was told I should instead take Tylenol to reduce my fever and address my pain. My fever and chills recurred last night at about 8pm and I took more Tylenol. Today, I am still experiencing some pain in my arm (injection site) and some chills/dizziness, but am taking Tylenol and have not experienced any recurring fever since last night. I am continuing to drink a lot of fluid and take a low dose of Tylenol at regular intervals.

Injection was given and burned on insertion. That evening and proceeding into next day I experienced loss of Range of motion in Left upper extremity, pain up to neck and down left arm, and back behind shoulder blade.

ER for restricted airway after 3 hours. Muscle pain, joint pain, extreme dizziness, sore throat, headache, cold hot sweats, fatigue, for 5 days. dizziness, sore throat, still after 6 days

Fever; Myalgias; Arthralgias; Costovertebral angle tenderness; Fatigue; This is a spontaneous report received from a contactable physician. A 30-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, in left arm, on 11Jan2021 at 18:45, for COVID-19 immunization. The patient received the first vaccine dose on 21Dec2020 at 16:00, intramuscular, in right arm, for COVID-19 immunization. No other vaccine was given in 4 weeks. The patient's medical history was none. The patient had no COVID before vaccination. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ). On 12Jan2021 at 13:00 the patient experienced fever, myalgias, arthralgias, costovertebral angle tenderness and fatigue. COVID was not tested after vaccination. No treatment was given. The events were resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

First vaccine chills and feverish but did not have a fever. Headache, nausea, joint pain, Body aches , runny nose, brain fog, fatigue and swollen lymph nodes . 2 days after the first vaccine. Second vaccine chills, feverish, runny nose, head ache and body aches, fatigue and feels like she is going to have swelling in the lymph nodes again.

Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 minutes every 30 minute or so) Tingling in my hands and finger tips.

Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and pain, and generalized fatigue resulting in inability to work the day after dose given. Fatigue started around 20:00 on 1/5/2021 (same date as 2nd dose administration), with increasing discomfort throughout the night. Symptoms continued until about 1:00 on 1/7/2021. Peak symptoms 1:00am-12:00pm on 1/6/2021.

Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and body still hurt; Felt sick; Broke out in hives all over my body; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain under my right breast/body still hurt; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 12Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included the patient had known allergies to Erythromycin and pineapple. The patient had Covid-19 prior vaccination on an unspecified date. The patient had other concomitant medications. On 12Jan2021 14:00, 1 hour after vaccine the patient broke out in hives all over her body. The patient went to the ER at around 2-3pm. Later that night the patient had extreme pain in her right arm, upper right side of her back and under her right breast. The patient called ER and they told the patient to monitor it. The next morning on 13Jan2021 the patient was exhausted, had a headache and felt sick. Her right arm was painful to touch or lay on. The hives went down some. On 14Jan2021 the patient woke at 7am and her lymph node in her right armpit was swollen. It's painful to lower her arm due to the swelling. The patient was still tired and now the patient had diarrhea (on 14Jan2021). The patient's hives were less noticeable today. Her head and body still hurt. The patient had been on bed rest. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects in Jan2021. Information on the lot/batch number has been requested.

On Monday, January 25, 2021, at 11:40am I received the second dose of a series for the Pfizer COVID-19 vaccine. Over the course of the rest of that day, I began to develop a headache and mild neck soreness. That night, I slept poorly. When I awoke just before 5:00am the next day, Tuesday, January 26, I did not feel well. I was experiencing headache, malaise, nausea, myalgia, arthralgia, and low-grade fever. I called my supervisor around 5:30am that day and we decided it was best that I stay home to recuperate. Throughout the day, I mostly rested and slept, took Tylenol, and began to feel better in the mid-afternoon. I did call and leave a voicemail for hospital Employee Health around 1:30pm on Tuesday the 26th, but did not hear back. Today, Wednesday, January 27, I am feeling much better, and well enough to come to work.

chills, stomach upset, and muscle aches within 24 hours of administration. Symptoms resolved without intervention.

immediate tingling in injected arm which went after 10 minutes photophobia and blurred near vision 30 mins after vacc 8 hours after vacc: severe headache, chills, joint pain over whole body, extreme fatigue, sinus congestion. these lasted over 24 hour period.

I did not feel the shot going in, so much so that I wished I had looked to see if I was actually vaccinated. About 6 hrs after vaccine, I felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine, my arm was so sore I could not lift it. That night I took two Tylenol and had to wrap my arm in a heating pad. I woke up around 3am that following morning with a fever of 104 F. I was so dizzy from the high fever. I felt extremely nauseated. My body ached mostly in my legs and lower back. It hurt to sit on the toilet, to put on clothes. My Fevers happened at night time ranging from 102-104F for 4 days. My injection site soreness lasted for 7 days. Body aches lasted around 2-3 days. Dizziness subsided after my fever broke, but was replaced with a severe headache lasting 2 days.

Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: dizziness burning sensation in the right side of her neck and r ear Lot: EL 3247 Time of Administration: 1:10pm in LEFT arm Time Symptoms Began: 1:40pm when she stood up. Felt a rush and then got dizzy She was given a pink card-dizziness and numbness in legs after last vaccine. For the next few days, she had intermittent dizzyness, nausea, extremely tired _____ Patient alerted observer who took the patient to the medical observation area. I was alerted and responded. She was sitting on the couch in the observation room. Initial Assessment @ _1:42om_: Patient is Patient is AAO. The employee is sitting up on the sofa. The employee is pink and does not appear to be in distress. She is talking and making conversation. She was given a Ginger Ale. We made convsersation for the next ~10 minutes. She was in no distress at all. Vitals @: 155pm HR: 79 BP: -- O2: 98 Employee was discharged without treatment. The RN was notified for follow up. Patient wil call us if anything progresses.

Muscle aches, chills, fever and night sweats within approximately 10 hours or second dose. Lasted for ~ 48 hours. Some relief with Tylenol.

I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hour mark I started having a heartbeat 15-20 bpm higher than my normal, chest tightness, difficulty breathing, and dizziness. I'm now 3.5 days post vaccine dose 1 and still having all of the symptoms in my last sentence plus extreme exhaustion, muscle pain, and fever.

12 hours post-injection patient experienced fever (100 degrees F), headache, lethargy, significant pain at injection site, chills, aching joints, and painful swollen lymph nodes in the armpit of the arm the injections was administered in. Symptoms resolved by about 36 hours post-injection. Only remaining symptom at 4 days post-injection is swollen lymph nodes, no longer painful.

My white blood count went really high; The first dose was on 28Dec2020 and the Lot: EH9899. The second dose 12Jan2021 at 7am, Lot: EL1284; Extremely achy/Body aches; Chills; Back hurts so bad that she can't lay down; Sweating; The first round of the vaccine she had flu like symptoms. This time, with the second dose, it is more severe; The first round of the vaccine she had flu like symptoms. This time, with the second dose, it is more severe; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the right arm, on 12Jan2021 07:00, at single dose, for COVID-19 immunization, in the hospital. The patient medical history and concomitant medications were not reported. The patient had no allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), via an unspecified route of administration, on 28Dec2020, for COVID-19 immunization and the patient had flu-like symptoms. The patient reported that with the first round of the vaccine, she had flu like symptoms. This time in Jan2021, with the second dose, it was more severe and if she didn't keep up with Tylenol, she was extremely achy, had chills, her back hurts so bad that she couldn't lay down, and sweating. The patient wanted to know if that was normal. The patient mentioned she called out of work for the rest of the week and left early on Tuesday. The patient stated that she had not been to the doctor at this point but when Tylenol wears off it was really ugly and would consider going. The patient stated that she was almost on septic. Her white blood count went really high on 12Jan2021 and was hospitalized from 16Jan2021. She was put on Cefepime, 2 gm per vial, gotten maybe 4 of them so far. Body aches was ongoing. Her blood work was getting better. The outcome of events white blood count went really high, extremely achy/body aches was not recovered.The outcome of other events was unknown. Follow-up (17Jan2021): New information from a contactable consumer (patient) includes: Reaction data (add event white blood count went really high, outcome of event extremely achy/body aches updated). This case has been upgraded to serious.

Maternal exposure during pregnancy; Maternal exposure during pregnancy; Maternal exposure during pregnancy; Muscle and joint aches in legs; Muscle and joint aches in legs; Shivering; fatigue; This is a spontaneous report from a contactable nurse. A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9231), intramuscular on 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included colitis ulcerative and hypersensitivity to sulfa drugs, tomato, nuts from an unknown date and unknown if ongoing. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]), colecalciferol (VITAMIN D [COLECALCIFEROL]). On 15Jan2021 22:00, the muscle and joint aches in legs, shivering and fatigue. The patient was 35 Weeks pregnant at the onset of the event. The patient was due to deliver on 26Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021 covid test result of Negative. The outcome of the eventsmuscle and joint aches in legs, shivering and fatigue was recovering.

Fever; chills; Restlessness; fatigue; constant headache; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back; This is a spontaneous report from a contactable healthcare professional reporting for self. This 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL 3302) on 17Jan2021 08:45 AM (vaccine location= Left arm) at single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number= EL1284) on 27Dec2020 09:15 AM (vaccine location= Left arm) at single dose for Covid-19 immunisation. Patient did not have other vaccine in four weeks, and did not have other medications in two weeks. No known allergies. Patient was not pregnant. The patient experienced fever and chills approximately 11 hours after vaccine. Restlessness, fatigue and constant headache. Periodic chest pain that radiates to upper abdomen and up on ears and neck and radiate to back. Fever went away about 16 hours after fever onset and was coming back approximately 36 hours after vaccine dose. The events onset date was reported as 17Jan2021 08:00 PM. No treatment received. Patient did not have COVID prior vaccination, did not test COVID post vaccination. Outcome of events was recovering.

Second vaccine: Day 2 noticed my armpit was tender. Upon palpation, noticed my lymph node was enlarged, 3-4x it?s regular size. Day 4 noticed shoulder pain this morning while jogging. The pain came and went until it was consistent and physically caused me stop running and walk. The soreness continued throughout my run and even 15-20 min after. It?s been a few hours and I still feel some soreness in my left shoulder.

About 12 hours after receiving second dose started feeling myalgias and that was the worst part and also chills, and then the headache (minimum) and probably about 8 hours after I started feeling the myalgia the Braxton Hicks started. And those contractions lasted a couple of days. I consulted my OB-GYN and they ended up in a couple of days. I felt like I was coming down with the flu for the next 12 hours or so after 24 hours after the vaccine I was brand new.

Pfizer-BioNTech. I suffered from chills, headache, joint and muscle aches, and nausea. The symptoms were severe from 7:30 pm on Monday, the day of the dose (vaccine received at 9:30AM), until 5:30 PM Tuesday (approximately 22 hours). The symptoms were relieved by taking extra strength tylenol every 4 hours. The symptoms were lessened, but still present until 9:30 AM on Wednesday. I was still suffering from a minor headache all day Thursday. I also had soreness in the injection site, there was no swelling or redness that I noticed; the soreness was mostly gone by Thursday. I have had a left eyelid twitch in the past (randomly), it returned after the vaccine and was very bothersome. Today is Thursday and the eyelid twitch is still bothering me.

Joint pain for two weeks so far since second dose/started by aching then becomes extremely sore and then goes away in one day; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283, expiry: unknown), via an unspecified route of administration in the left arm on 08Jan2021 08:30 at a single dose for COVID-19 immunization on a hospital. Medical history included ADHD. The patient has no known allergies and no Covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 18Dec2020 at 13:00 in the right arm for COVID-19 immunization. The patient experienced joint pain for two weeks so far since second dose (08Jan2021 09:30). It started in the left shoulder of the arm she received it in. That same day, it started in her knee on the left side, then went to both knees, moved to her right shoulder then left shoulder then to her right elbow for one day. Now it's her left shoulder again for one day. It started by aching then becomes extremely sore and then goes away in one day. The event was not treated. The patient was not tested for Covid post vaccination. The outcome of the event was recovering.

I got it that morning at 9am ,that evening I started to have chills and fever to 103. It continued through the night until the next day. I was having serve muscle pains and difficult walking my myself. This lasted about 22 hours. I contacted my Doctor but did not go in.

At around 3 am started intense shivers, temp was over 100, spent night with chills and shivers, and couldnt move my injection site arm due to pain. Next morning, had intense headache, joint pain, and my eyes burned. Couldn't get up without assistance because of how weak I was. Fever 102.6 around noon took tylenol. Don't think i have ever felt this sick in my life. Fever all day over 100. Sweating, muscle and joint pain (worse at joint between neck and head, hips and wrists). Nausea throughout, had soup to hydrate at around 5pm. Started to feel better but fatigued still with fever of 100 by midnight. Spent night sweating with headache, woke up 2/7 still with 99.8 temp, much lower temp without tylenol. Throughout the day i have had joint and muscle aches, and fatigue, a mild headache. Finally around 4pm stated to improve, haven't had a fever since noon, still achy but have a little more energy.

Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. About 12 hours post-vaccine, uncontrollable muscle spasms began and lasted approximately 2 hours. In this time, arm/shoulder/lymph node were extremely swollen. During the muscle spasms, I experienced my first or two "attacks". Speaking and thinking became difficult - at times I felt as though I was trapped in my own head unable to speak or move how I wanted (motor function was possible but sluggish and requiring assistance to become ambulatory). The worst of this lasted about 4 hours, though my brain remained some level of "foggy" 48 hours post-vaccination. 1-2 hours into these neurological issues, I lost the ability to feel throughout my whole body. I could tell there was a sensation on my skin, but I could not tell if it was hot/cold/pain/pressure. I could not feel if I was swallowing, drinking water, or breathing, though I could move enough to perform these activities. Vision was hazy during these attacks and for a while after. The worst of all these effects lasted 3-4 hours. It then took about 5-6 hours to regain all feeling, though my brain was still foggy/hazy. Heavy swelling lasted several hours, then became moderate swelling, and after 48 hours, there was little to no swelling. About 22 hours post-vaccination, I had another one of these "attacks", not including the muscle spasms. This second attack was identical to the first in every way, except it was slightly less severe. Recuperation time was again 5-6 hours. It is currently about 70 hours post-vaccination and most symptoms except moderate arm soreness are gone. During both attacks, BP and temperature were normal, heart rate slightly elevated (80-85 bpm). Other non-severe effects included fatigue, slight chills/flush.

Nausea; Elevated Heart Rate (24+Hours After); Tingling; Numbness of the arm (24+ Hours); Pain in the armpit (started approx 36 hours after the injection; Fever; Pain in hips and entire back; Pain in hips and entire back; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Lot number: EJ1686), via an unspecified route of administration in left arm on 19Jan2021 15:45 at single dose for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previous received first dose of bnt162b2 (Brand: Pfizer, Lot number: EK9231), via an unspecified route of administration in left arm on 29Dec2020 07:00 AM for covid-19 immunization. The patient experienced nausea, elevated heart rate (24+hours after), tingling, numbness of the arm (24+ hours), pain in the armpit (started approx 36 hours after the injection), fever, pain in hips and entire back, headache (24+ hours) all on 19Jan2021 19:30. The patient underwent lab tests and procedures which included heart rate: elevated on 19Jan2021. The outcome of events was not resolved. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received. No other vaccine in four weeks. Other medications in two weeks: Birth control. No COVID prior vaccination. No COVID tested post vaccination. Not known allergies. No follow up attempts are possible. No further information is expected.

muscle aches; nausea; fever, Tmax 101.7; neck ache; soreness at sight of injection; This is a spontaneous report from a non-contactable nurse. A 30-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3247), intramuscularly on 21Jan2021 at 09:15 AM in the Left arm at single dose for COVID-19 immunization in hospital. Medical history included hasimoto's, known allergies with peanuts. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscularly on 30Dec2020 at 08:15 AM in the Left arm at single dose for COVID-19 immunization at the age of 30-year-old. The patient experienced fever, Tmax 101.7, muscle aches, neck ache, soreness at sight of injection, nausea on 21Jan2021 at 23:30. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included mefenamic acid (ADVIL). The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

I received the shot around 1:45 pm and I felt a warm/ burning sensation in my arm. I waited there for 15 minutes and nothing happened. I get home and still felt fine. Around 6:30 pm I started to feel neck pain and stiffness as I continued to do house chores the pain just kept going up towards my neck into my left cheek where I feel numbness. My throat and jaw hurt as well. My neck is stiff and I can?t look to the left unless I turn my body. The back my head is also starting to hurt. My arm is sore where the shot was given but what hurts most is my neck, throat and head. I have body chills but no fever. I took Tylenol and called the dr on demand who told me to take Benedryl and if the symptoms got worse to go to the hospital.

diarrhea (7+ loose stools each day starting on this day); headache; severe nausea; worsened muscle pain; new joint pain morning after (Included in aforementioned, but significant stiff neck.); new joint pain morning after (Included in aforementioned, but significant stiff neck.); fatigue/malaise; fatigue/malaise; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) Intramuscular at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Other medications in two weeks includes fluoxetine, lorazepam, and Ibuprofen. Patient received first dose of bnt162b2 (lot number: EL0140) on 30Dec2020 and experienced injection sight tenderness, severe headache and fatigue. On 20Jan2021 5:00 PM after the second dose, patient experience headache, severe nausea, diarrhea (7+ loose stools each day starting on this day), worsened muscle pain several hours later, new joint pain morning after (Included in aforementioned, but significant stiff neck), fatigue/malaise. Patient received Ibuprofen and rest, supportive care due to events. The outcome of event was not recovered. Rapid Nasal Swab tested Negative on 21Jan2021.; Sender's Comments: The reported event diarrhea was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship, and considering no alternative cause reported currently. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Progressive muscle aches, deep - in left arm (arm of injection), bilateral legs, and low back; fatigue; Chills; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration in the left arm on 22Jan2021 10:15 at a single dose for COVID-19 immunization. The vaccine was given in a hospital. Medical history included IBS (irritable bowel syndrome) and known allergies: Sulfa. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. The patient had not been tested for COVID post vaccination. The patient has not received any vaccine in 4 weeks. Concomitant medication included macrogol 3350 (MIRALAX), Olly prenatal gummies and unspecified blood builder. On 23Jan2021 at 2pm, the patient experienced progressive muscle aches, deep - in left arm (arm of injection), bilateral legs, and low back. Also chills and fatigue. There was no treatment given for the events. The outcome of the events was recovering. Information on the Lot/Batch number has been requested.

She reports with a few minutes she felt light headed, dizzy and mentally disconnected. Symptoms included feeling nonspecific discomfort, hot, cold, palpitations, nausea. She states her chest cavity felt strange and can best describe it as internal burning. She states breathing was strange, and was 'almost' SOB. She felt palpitations. They seated her in a chair for 15 minutes and observed her for 35-45 minutes. Her VS were normal. She denies pruritis, urticaria, flushing, sweating, cough, wheeze, oral/facial/throat/tongue swelling, red/watery eyes. She went home and continued to feel uncomfortable and restless. She had one emesis. She took a Tylenol pm at 19:00 and slept until about midnight. She reports the restlessness and discomfort stopped, but she then felt flulike symptoms (malaise, myalgias) for the next 3 days. She noted onset of edema at the injection site day 1, but no erythema or dermatitis.

fever of 104 F; dizzy; my arm was so sore I could not lift it/ My body ached mostly in my legs and lower back; felt soreness at the injection site; felt extremely nauseated; My body ached mostly in my legs and lower back; Body aches/extreme tiredness; headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EJ1686. Medical history and concomitant medications were unknown. Historical vaccination included flu vaccine for immunization (vaccination site pain). About 6 hrs after vaccine on 07Jan2121, the patient felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine on 07Jan2021, arm was so sore that the patient could not lift it. That night the patient took two Tylenol and had to wrap arm in a heating pad. The patient woke up around at 03:00 on 08Jan2021 with a fever of 104 F; the patient was so dizzy from the high fever. The patient felt extremely nauseated on 07Jan2021. Body ached mostly in my legs and lower back on 07Jan2021. It hurt to sit on the toilet, to put on clothes. On 07Jan2021, the patient experienced body aches/extreme tiredness. On 07Jan2021, the patient experienced headache 8as reported). Fevers happened at night-time ranging from 102-104F for 4 days. Injection site soreness lasted for 7 days. Body aches/extreme tiredness lasted around 2-3 days. Dizziness subsided after fever broke, but it was replaced with a severe headache lasting 2 days (as reported). The patient was not COVID tested post vaccination. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.

Fatigue; Chills and Sweats; Chills and Sweats; Fever (102); Headache; Muscle aches; Weakness; Cough; Out of Breath; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient receives the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose at left arm on 27Jan2021 14:30 at 30 years for covid-19 immunisation, administered at hospital. Medical history included bladder cancer. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications within 2 weeks of vaccination. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # E1L9L31) at single dose at left arm on 04Jan2021 for covid-19 immunisation. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 01:00 the patient experienced fatigue, chills and sweats, fever (102), headache, muscle aches, weakness, cough, out of breath. The patient underwent lab tests and procedures which included body temperature: 102 on 28Jan2021. No treatment received for the adverse events. Since the vaccination, has the patient been not tested for COVID-19. The outcome of events was recovering. Case was reported as non serious. No follow-up attempts are possible. No further information is expected.

The night after the second dose, I had difficulty sleeping, but that was not particularly unusual. By about 10 the next morning, I started getting joint aches in bilateral hip joints and sacral joints. By 10:30 I suddenly found myself lightheaded and had to sit down so as to not faint. Of note, I had just previous to this lightheadedness donned full PPE to work with a patient (gown, gloves, face shield, N95), not having yet worn it that morning. I did not faint, and was able to sit down for 15 minutes without a mask and drink ice water, but I was not safe to work with my patients (as a physical therapist). I left work and went home to sleep. I did not have a fever or chills. After a 3 hour nap, all of my symptoms resolved. Additional information: I am pregnant, was 16 weeks pregnant at the time. All fetal imaging prior to the first vaccine and after the second vaccine have showed normal healthy development. I am due July 3

Fever 102.7, loss of appetite, vomiting, chills, headache, muscle ache. Resolved on their own in 36 hours. Used Tylenol to reduce fever.

1/8 vaccination 1/9 I woke up with severe HA, muscle aches, and fatigue. That evening I got chest pains. 1/10 CP resolved. Everything resolved. 1/17 positive pregnancy test 1/22 miscarriage. First pregnancy. 2/10 finally able to see dr.

intermittent pain on my left hand-arm only: from fingers to elbow The pain came like waves, intensified within 5-10 minutes, and stayed at that pain level:6 for 2 hours. At that time I couldn't use my left hand at all. The total duration of each episode is around 4-5 hours and it almost turned to normal afterward. I had 6 cycles of intermittent pain. 02/08/2021: one in the afternoon, one in the evening It started on my fingers (left hand). restriction with the movement due to pain and weakness. I could still hold objects but it hurt and I didn't want to use my left hand at all. I took OTC ibuprofen in the afternoon, but it didn't help. 02/09/2021: woke up at 6-7 am due to pain. the pain reached to my elbow. total of 3 pain cycles. 02/11/2021: 1 mild pain cycle and then the pain resolved.

Parsonage Turner Syndrome. Severe debilitating pain in right shoulder beginning 2/2/2021 that became progressively worse throughout the day. Decreased range of motion, unable to lift/move arm by evening. The following day range of motion gradually returned but was clunky and limited. Over the next 4 days profound weakness with intermittent sharp stabbing pain in the joint. Utilized ibuprofen, Tylenol, flexeril, and heat with minimal relief. PCP 2/11/2021 prescribed medrol dose pack, x-ray shoulder, mri shoulder and referral to ortho. 2/11/2021 X-ray normal. 2/24/2021 Mri showed disfuse fluid signal with recommendation to pursue neurogenic approach. Saw Ortho on 2/19/2021. They ordered PT, scheduled to begin 3/17/2021 (first available). Spoke with PCP 3/1/2021, referral to physiatry placed for EMG and possible joint injection. Have been utilizing NMES and doing basic range of motion exercises. Continue to have severe muscle weakness.

Pain at injection site, fever, chills, joint aches, overly sensitive to physical stimuli. Began about 6 hours after vaccine was administered and lasted about 24 hours. Standard OTC dose of ibuprofen every 6 hours provided slight relief.

whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; little chest pain; minor fever; blood pressure dropped; dizziness; backpain; left arm felt sore; sleepy/light drowsiness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 11Feb2021 15:30 at a single dose (at the age of 30-years-old) for COVID-19 immunization. Medical history included >13 years ago: diagnosed TB with no symptom, completed TB treatment 1 year-plan and has issue no since then; >16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward. The patient was not pregnant. Concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 21Jan2021 at 13:15 on the left arm at a single dose (at the age of 30-years-old) for COVID-19 immunization. After about 4.5h post-vaccination (20:00), her left arm felt sore and within the next 3h, she felt sleepy and experienced random light drowsiness. She woke up around 06:30 the next day (12Feb2021) only felt continued sore arm. However, at 08:30 to 09:30, her whole body felt sore and exhausted, especially back pain, as if she having a bad cold/flu. She also felt a little chest pain, had a minor fever and went sleeping from 12:00, woke up around 18:00-19:00. The whole body ache was almost gone but her back was still in pain and her blood pressure dropped with random dizziness when she was walking or standing up. The next morning (13Feb2021), the back pain was gone and she felt it back to normal except for a little random dizziness in movement. She did not take any medication to alleviate the adverse effects during the timeline. The patient was not COVID tested post vaccination. The patient recovered from back pain in 13Feb2021, the patient recovered from the remaining events in Feb2021.

After my second Covid19 vaccine shot I developed symptoms such as headache, back aches, a rash, and fatigue. This started at 6 am the next morning after the vaccine, and lasted for 24 hours. Except the headache which lasted about 48 hours. Rash is going away, but still itchy on bottom half of body.

Fever, chills, body aches, fatigue, muscle weakness, and injection site pain, redness and tenderness.

A few hours after the vaccine I started feeling fatigued and having chills. I was so tired and sleepy I slept almost all day for the first 48 hrs after. Developed fever between 100.5-101 which lasted about 18hrs which did require me to have to call into work the following day. 2/3 I developed swelling and pain in the lymph nodes under my right arm and breast. The swelling subsided within 4days but I still have some tenderness to date. I took tylenol and ibuprophen for the first 48 hours to help with all the symptoms.

Mild anaphylaxis about 20 minutes after dose. Abrupt painful tightening of the throat, no real difficulty breathing. My face felt "buzzy" but didn't swell and I did not have significant itching. I have had similar reactions in the past to cleaning products and pesticides and usually take a benadryl, though I do carry an epipen and had one with me at the time. Instead of going back in the convention center for medical attention I took a benadryl and waited in the parking garage for about an hour and felt the throat restriction ease a bit. About 10 hours later around 8pm the tightness came back suddenly over about 10 minutes and I took another benadryl. The next morning around 7am I had one more round of tightening and took one more benadryl, and it stopped after that. I told my doctor about it a few days later.

Muscle pain and tightness at injection site. Not being able to lift arm past shoulder height. Pain with touch or movement of arm. Severe headache, joint pain, generalized body aches, low grade fever, fatigue, chills, nausea and weakness. Called in sick to work. Rest, drinking water, a hot bath, muscle ache cream, alternating Tylenol and Motrin.

20 minutes after injection inner ear pressure, light headedness, dizziness, faintness. Three hours after injection low grade fever, dizziness, fatigue. 24+ hours after injection headache, fever, arm soreness, inner ear pressure, hot flashes, neck tension, eye "floaters"

I had a migraine for three days starting on wed and burning tingling and numbness in my hands feet back of my calf also, my veins in my wrist hurt and felt tight and by Friday night my face was starting to get numb. I also have a bad sore throat. I went to the hospital they ruled out blood clot and stroke. My Covid test was negative.

She says she had her second dose of the COVID vaccine on Saturday 3/13/2021 and she woke up that night around 1 am with lots of pain in her armpit and neck with dizziness. Before she could go sit down she passed out. She later woke up on the floor, got up and threw up. Since then her neck and shoulders area has been more tense and tight than normal. She says that other than muscle tension she feels "back to normal" now (three days later).

JIA flare-up (inflammation in jaw, knees, ankles) H. Sup flare-up (inflammation if skin, increase in active spots)

17 weeks pregnant at the time of vaccination. Due August 23rd. For about 24 hours, starting 14 hours post vaccination, I experienced muscle and joint pain, chills, fever, nausea, dizziness, vomiting, and diarrhea. I treated with tylenol. Symptoms went away within 24 hours of presenting.

10 minutes after shot experienced vagovasal episode. Had a headache, sore muscles, and tiredness for 3 days after shot. Experienced a low grade fever and chills the 4th day on and off. Experienced brain fog for about 6 days.

I received the 1st vaccine on 1/8/2021 and immediately my arm was very sore but was fine a few day after. however when i got my second vaccine on 2/4/2021 is when I began to experience more side effects. My arm was extremely sore for more than a week. I could barely fully extend my entire arm and I developed a lump in the pit of my arm pit. Both my tricep and bicep mussels were tender. I also experienced headaches and tinnitus. The soreness of my arm and lump have gone away however I still have headaches and tinnitus to this day.

Night after vaccine severe chills, muscle aches. When waking in morning, had neck pain and muscle spasms. Was in severe pain in neck with difficulty swallowing. Went to urgent care and was given muscle relaxers. Pain continued for 3 weeks after, severe still. Began chiropractor visits, no improvement. Had MRI completed, showed golf ball sized lymph node swelling in neck on side of severe pain. Went to ENT for course of steroids with mild improvement. Still having mild to moderate neck pain everyday and it has been 2 months since vaccine. Would never get this type of vaccine again, and I am a medical professional who usually trusts them.

Muscle soreness most of day 1 Slight nausea throughout day 1 Had to take ibuprofen to relieve the muscle soreness

Chills, muscles aches, nausea, and headache suddenly set in at 9:30pm on the same day as second dose, ibuprofen helped and all these symptoms were gone by Saturday 03/27/2021 morning. Sore arm started earlier but was manageable pain and longer lasting.

forcing out/stumbling over words as I struggle to stay awake; profound fatigue; forcing out/stumbling over words as I struggle to stay awake; Limbs are heavy; This is a spontaneous report from a non-contactable other healthcare professional (patient). This 30-year-old female patient received the second dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 01Mar2021 09:00 AM on the left arm for COVID-19 immunization. The vaccine was administered at a Health Clinic. She did not receive any other vaccines in four weeks prior to receiving BNT162B2. The patient had no COVID prior to vaccination. The patient was not pregnant. Medical history included depression and had unspecified known allergies (known allergies: Yes). Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), on 08Feb2021 09:30 AM on the left arm for COVID-19 immunization at the age of 30-years-old. On 02Mar2021 12:00 PM, the patient experienced profound fatigue; feel like I forcing out/stumbling over words as I struggle to stay awake. Limbs are heavy. No corrective treatment was received. Outcome of the events was not recovered. The patient has not been covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

cardiac arrhythmia; dizziness/lightheadedness; nausea; muscle weakness; extreme fatigue; lost consciousness/She is in and out of consciousness; extreme weakness; extremely low blood pressure; tachycardia when resting/heart rate is high/HR gets up to 135; One foot and leg became very cold and turned blue; One foot and leg became very cold and turned blue; other foot warm and hot; This is a spontaneous report from a contactable consumer (patient's sister). A 30-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EN/ EW 6198; expiration date: unknown), at vaccination age of 30-year-old via an unspecified route of administration in the left arm on 02Mar2021 as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with covid prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EN6198), at vaccination age of 30-year-old via an unspecified route of administration in the left arm on 09Feb2021 as a single dose for covid-19 immunisation but had weakness, fainted, lost consciousness and concussion. There were no concomitant medications. The patient did not receive other vaccine in four weeks. The reporter mentioned that on the next day after vaccination (03Mar2021), the patient's one foot and leg became very cold and turned blue other foot warm and hot started cardiac arrhythmia, dizziness, lightheadedness, nausea, muscle weakness, extreme fatigue, extremely low blood pressure and tachycardia when resting. The reporter stated that since 02Mar2021, she hasn't been able to get out of bed due to extreme weakness. The reporter also mentioned that her heart rate (HR) gets up to 135 [unit unspecified]. The reporter also stated that the patient was wearing a heart monitor and was waiting for data. They went to the emergency room (ER) on 12Mar2021 due to concerns of blood clot, ruled out blood clot. The doctors can't explain what is happening to her. She was extremely healthy and fit, no previous cardiac or energy issues. No blood pressure issues or family HX. She says she "feels like she's dying". The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life-threatening illness (immediate risk of death from the event). The hospitalization was reported as 1 day. It was unknown if the events received treatment. The patient was not tested post vaccination. It was further reported that her sister had the second Covid shot 02Mar2021 and a few hours later she lost consciousness. She has been in the hospital ever since. She was in and out of consciousness, her blood pressure is low, and her heart rate is high. One of her legs is blue and cold, the other is hot. She cannot get out of the bed. The doctors don't know what is wrong. It was mentioned that the patient was healthy and not taking any medication. The outcome of the events was not recovered.

Heartbeat 15-20 bpm higher than my normal; Chest tightness; Difficulty breathing; Dizziness; Injection site pain; Headache; Tiredness/ Extreme exhaustion; Muscle pain; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9261), via an unspecified route of administration on Arm Left on 25Jan2021 18:30 as single dose for COVID-19 immunisation in hospital. Medical history included seasonal allergy and Known allergies. Concomitant medications included unspecified medications received within two weeks. The patient did not receive other vaccines within four weeks. The patient not had COVID prior vaccination. The patient was not tested for COVID post vaccination. On 25Jan2021 22:30, the patient was totally fine for 4 hours. After 4 hours she started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hours mark (on 26Jan2021), she started having a heartbeat 15-20 bpm higher than her normal, chest tightness, difficulty breathing, and dizziness. She was now 3.5 days post vaccine dose 1 and still having all of the symptoms in her last sentence plus extreme exhaustion, muscle pain, and fever. The events result in doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a for all the events. The outcome of the events was reported as not recovered.

The arm that I received the vaccine is still swelled/puffy; The arm that I received the vaccine is still swelled/puffy; muscles are sore; lymph node is swelled/puffy; still in pain and discomfort; still in pain and discomfort; This is a spontaneous report from a contactable 30-year-old female consumer reported for herself. A 30-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 30Jan2021 12:30 as single dose for covid-19 immunisation. Medical history included asthma, blood pressure increased, and allergies: penicillin. Concomitant medication included biotin (BIOTIN) and multivitamin. On 01Feb2021 the patient had, the arm that I received the vaccine is still swelled/puffy, muscles are sore, arm pit/lymph node is swelled/puffy, still in pain and discomfort after 5 days. The was no treatment for the events. Facility the most recent COVID-19 vaccine was administered in Hospital. The outcome of the events was not recovred

After injection pt was escorted by RN to observation area. In route, patient passed out. Color became dusky. Spo2 was 88-100 %. Dr ordered Epi Pen to be administered to left thigh at 1258. EMS was notified and patient taken to Hospital. Upon arrival to ED pt reports she became suddenly dizzy then woke up in the ED. She experienced chest tightness, sore throat, tongue swelling. Second epi was given in the ED. Developed muscle stiffness in the ED.

This is a 30-year-old female with no significant past medical history who presents to RMC ED with complaints of acute onset headache and left-sided weakness shortly after receiving her first Pfizer COVID-19 vaccine today. Patient states that after the injection she immediately had a headache and several minutes later she developed left-sided numbness tingling and subsequent weakness. She was activated as a code stroke. CT head, CTA head and neck were unremarkable. Patient was evaluated neurology was thought that her symptoms are likely related to vaccine reaction as opposed to acute CVA she is not given TPA. Upon my assessment patient states that she continues to have left-sided weakness both her arm and her leg. She has decreased sensation on her left side. She is able to move her left extremities however she states that they feel heavy and weak. Patient was given Benadryl IV as well as famotidine in the ED. She will be given Solu-Medrol as well. Patient denies any history of any vaccine reactions in the past, to penicillin and seasonal allergies otherwise denies any sensitivities. Denies any history of autoimmune diseases. Patient denies any HA, dizziness, vision changes, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, fevers chills, dysuria. This is a 30-year-old female with no significant past medical history who presents to RMC ED with complaints of acute onset headache and left-sided weakness shortly after receiving her first Pfizer COVID-19 vaccine 4/9/21. Patient states that after the injection she immediately had a headache and several minutes later she developed left-sided numbness tingling and subsequent weakness. She was activated as a code stroke. CT head, CTA head and neck were unremarkable. Patient was evaluated neurology was thought that her symptoms are likely related to vaccine reaction as opposed to acute CVA she is not given TPA. Admitting physician felt she has decreased sensation on her left side. She is able to move her left extremities however she states that they feel heavy and weak. Patient was given Benadryl IV as well as famotidine in the ED. She will be given Solu-Medrol as well. Patient denies any history of any vaccine reactions in the past, to penicillin and seasonal allergies otherwise denies any sensitivities. Denies any history of autoimmune diseases. Pt has improved. She is able to move her LUE and LLE now. " Does not feel like moving bricks " Her tingling has decreased and she is able to feel things again with her left hand and leg. Pt had c/o chest pain 4/11/21. Her trop have been neg. EKG neg. D-dimer within normal limits. Will give dose of mobic 7.5 mg. Will try lidoderm patches for pain. Pt will follow up with pcp in 1-2 weeks.

Site: Pain at Injection Site-Medium, Additional Details: patient reported that she experienced numbness after inection which disappeared afterwards, but she is still experiencing a stiff neck 3 days after receiving the vaccine and is concerned about getting the second dose. I recommended her for a follow up with her primary care which she said she doesn't have and to go to the urgent care if pain is unbearable. patient is concerned that she may have experienced a pinched nerve after the shot itself.

Woken from sleep approx 11hrs after shot. Chills, mild fever, uncomfortable, joint pain including wrists and fingers, lymphnode in left armpit sore. As time went on alternated between chills and sweats. Symptoms continued for approx 36hrs. Lympnode soreness lasted approx 3days

severe dehydration from vomiting; severe dehydration from vomiting; very bad headache; body aches; was going from shivering to over heating; esophagitis; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the right arm on 29Mar2021 16:00 (Batch/Lot Number: EP6955) as single dose (at the age of 30-years-old) for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient was negative for the nasal swab on 03Mar2021. The patient received the first dose of BNT162B2 intramuscularly on the right arm on 08Mar2021 16:00 (at the age of 30-years-old) for COVID-19 immunization. The patient had no other medication in two weeks and no other vaccine in four weeks. The patient had no COVID prior to vaccination. After about 4 hours of receiving second dose (29Mar2021, 19:00), the patient had a very bad headache, body aches, and was going for shivering to overheating. She began to vomit non-stop, couldn't keep food or liquids down. She ended up going to urgent care on 30Mar2021 and was sent to the ER. She was admitted to the hospital on that day for severe dehydration from vomiting and was told she had esophagitis. The adverse events resulted in doctor or healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for three days. The patient received unspecified IV's, medications and had scans (unknown results). The patient was recovering from the events.; Sender's Comments: The events was considered related to suspect vaccine BNT162B2 based on strong temporal association and known safety profile of the drug. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate

fever 104 Fahrenheit; Severe swelling of right armpit lymph node accompanied by severe pain; Severe swelling of right armpit lymph node accompanied by severe pain; Severe swelling in right breast; Severe headache; Pain in chest when breathing; Pain in chest when breathing; This is a spontaneous report received from a contactable consumer (reported for herself). A 30-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 12:00 (Lot Number: EW0162) (Age at vaccination: 30 Years) as single dose for covid-19 immunisation. Medical history included Intracranial hypertension, sulfonamide allergy. The patient's concomitant medications were not reported. The patient previous received the first dose of bnt162b2 (lot number: EN6204) in Arm right on 17Mar2021 10:00 (Age at vaccination: 30 Years) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 08Apr2021 03:00, the patient experienced Severe swelling of right armpit lymph node accompanied by severe pain, Severe swelling in right breast, Severe headache and fever 104 Fahrenheit, Pain in chest when breathing. No treatment received for the adverse events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

pneumonia; kidney infection; severely dehydrated; extreme joint pain; fever; chills; uncontrollable shaking; Severe headache; nausea; vomiting; When Coughing, feel pain in uterus; When Coughing, feel pain in uterus; Very sick; weak; This is a spontaneous report from a contactable consumer, the patient. This 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533), via an unspecified route of administration in the left arm on 03Apr2021 10:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. There is no medical history reported. Concomitant medication included celecoxib (CELEXA). The patient did not have any allergies to medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E46955), via an unspecified route of administration in the left arm on 11Mar2021 10:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Two hours after the vaccination on 03Apr2021 at 12:00, the patient experienced extreme joint pain, fever, chills, uncontrollable shaking; severe headache, nausea and vomiting. No change after 3 days, she went to Emergency Room ended up with pneumonia, a kidney infection and severely dehydrated. She was hospitalized for one day (in Apr2021). When coughing, she feels pain in her uterus. She was very sick for 11 days after the vaccination and was still weak, and her joints continue to hurt. Therapeutic measures were taken included fluids, antibiotics, blood tests and nausea medications. Since the vaccination, the patient had been tested negative for COVID-19 virus via a nasal swab test on 06Apr2021. The patient had recovered with lasting effects from the extreme joint pain, fever, chills, uncontrollable shaking, severe headache, nausea, vomiting, pneumonia, a kidney infection, severely dehydrated, when coughing, feels pain in uterus, and very sick.

exhausted / Fatigue; she could hardly sleep; Mild sore throat; Headache; No energy; Myalgia; Arthralgia; This is a spontaneous report from a contactable physician. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 18:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing asthma, attention deficit disorder, and depression. Concomitant medications included ongoing methylphenidate hydrochloride (CONCERTA) for attention deficit hyperactivity disorder and ongoing bupropion for depression. Family history included brother had Covid. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Apr2021, the patient developed headache (important medical event - IME), no energy (disability), myalgia (disability), arthralgia (IME), and mild sore throat. On 18Apr2021, she could hardly sleep and exhausted/fatigue (disability). The patient had no shortness of breath, even though she has asthma and it was not an anaphylactic reaction. The patient took TYLENOL for the events which helped somewhat but didn't relieve it fully. It resolved as time passed. The outcome of the events headache, no energy, myalgia, arthralgia, mild sore throat was recovered on 18Apr2021. The outcome of the events could hardly sleep and exhausted/fatigue was recovered in Apr2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE0 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Angioedema of left arm at the inoculation site; Pruritus; Inflammation; Pain; edema; Lethargy; arthralgia/shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 20Apr2021 at 11:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included penicillin allergy, HAE (hereditary angioedema), endometriosis, narcolepsy and depression, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received NSAIDs for an unspecified indication on an unspecified date and experienced allergy. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 30Mar2021 at 16:15 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunisation. Concomitant medications (other medications in two weeks) included bupropion, desvenlafaxine, oxybate sodium (XYREM) and icatibant, all taken for unspecified indications on unspecified dates. The patient did not receive another vaccine within 4 weeks prior to the COVID-19 vaccination. On 20Apr2021 at 13:15 the patient experienced angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain. The clinical course was reported as follows: "Angioedema of left arm at the inoculation site. Diameter of 70 mm. Pruritus subsided within 72 hours. Inflammation remains at present: Approx 96 hours after injection. Pain accompanies edema when pressure is applied. Lethargy and arthralgia for 72 hours. Shoulder joint pain. Note: patient's arm is thin; angioedema extended from anterior to posterior sides of the arm." The patient did not receive treatment for the events. The clinical outcomes of the events angioedema of left arm at the inoculation site, pruritus, inflammation, pain, edema, lethargy and arthralgia/shoulder joint pain were recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19.

Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours - tylenol and heat/ice (no change) chills without fever overnight the night of - no treatment soreness in arm 1 hr post to up to its worst at 24 hours later when I could not abduct >90 degrees for 24 more hours

Immediately I got nauseas and headache. Next day my whole lower back was spasm and had horrible body pain/back pain. I almost passed out putting pants on. A friend took me to an Urgent care they gave me Shot of tramadol and given Tylenol 3. They also did a test on my kidney. About 50 hours after the shot I was feeling better.

DEVELOPED SWOLLEN LYMPH NODES AND SORENESS ON NECK AND JAW (LEFT SIDE). WENT TO THE ER AND IS FOLLOWING UP WITH MD ON 1/5/21

fever. Highest temperature was 101.1 F. I took tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total; back aches/achiness were better after sleeping for the night; headache; Fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left arm on 24Dec2020 08:30 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Baseline leukopenia. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 12 hours after the vaccine the patient developed back aches, headache, and a fever. Highest temperature was 101.1 F. The patient took Tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total. Fatigue and achiness were better after sleeping for the night. Events onset date was provided as 24Dec2020 11:30 PM. No treatment was received for the events of back aches, headache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event fever was recovered on 25Dec2020 04:30, the outcome of the other events back aches, headache and fatigue was recovered on an unknown date in Dec2020.

I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; Hypertensive; Tachycardiac; This is a spontaneous report from a contactable physician (patient). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 22Dec2020 for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) at 112 ug on 22Dec2020 for hypothyroidism. Physician stated, "I was about 2 minutes after the administration of vaccination on 22Dec2020, I have got tingling in both of my arms as well as hard to describe but like a lightness, it's like my arms felt very light. And they observed me and took my vitals and I was definitely hypertensive and tachycardiac". The outcome of the events was unknown. The vaccine was administered at Hospital Facility.

fever; myalgia; body ache; fatigue; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number ek5730) intramuscular in the left arm on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 24Dec2020, the patient experienced fever, myalgia, body ache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. After the vaccination, on 26Dec2020, the patient was tested for COVID-19 with a nasal swab which resulted negative. At the time of the report, the outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

sore arm (unable to lift without aching/hurting) for 2-3 days (improved each day, worst the day after vaccination) chills, low grade temp of 100.4F (went down with Tylenol), malaise, myalgia for one day starting the day after vaccination (Sunday evening and resolved by Monday morning)

Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing)/ Left and right neck pain; Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing); Arm Pain at injection site; Arm Pain at injection site; This is a spontaneous report from a non-contactable physician (patient). A 31-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: EK5730), intramuscularly on 22Dec2020 09:45 at single dose on left arm for COVID-19 immunization in hospital. Medical history included gastrooesophageal reflux disease (reported as GERD). No true allergies; unable to take NSAIDs or eat bananas or avocados 2/2 GERD. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain at injection site on Day 1 (22Dec2020); chest, back and left neck pain (chest and back pain worse with breathing) on Day 2 (23Dec2020); left and right neck pain on Day 3, resolved on Day 4. No treatment received for the adverse events. The events outcome was resolved on 25Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. No follow-up attempts are possible. No further information is expected.

headache; body aches; fatigue; still was feeling achiness in the arm and wrist; still was feeling achiness in the arm and wrist; some tingling feeling in the fingertips or feet; This is a spontaneous report from a contactable pharmacist (patient). A 31-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date was unknown, via an unspecified route of administration on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if tingling in feet or fingertips a common adverse effect of the vaccine. The patient experienced headache, body aches, fatigue after receiving the shot. Yesterday at 6PM, she still was feeling achiness in the arm and wrist. She took Ibuprofen and started feeling some tingling feeling in the fingertips or feet. The outcome of the events was unknown. The following information on the lot/batch number has been requested.

Ten minutes after Covid vaccine begin to feel "itchy" , lips tingling/itchy; dry heaving, chest pressure.E rythematous rash on face. Evidence of excoriation on neck and upper chest. No shortness of breath Rapid response team called and transported to ED. Received epinephrine, Benadryl, Pepcid, Zofran and Solu-Medrol. Discharged at 8:20 PM home. E Today she is experiencing: itching all over, lips tingling, legs and arms feel very heavy, weak. Will follow up with her healthcare provider MD @ Hospital.

EE reports fever of 100.3, achy, muscle and joint pain, and HA. Treatment with Tylenol with no improvement. She will continue to monitor.

Muscle aches, joint pain, fatigue, nausea, chills, fever, delirium from fever. Symptoms lasted 22 hours.

Significant arm pain at site of injection starting at 5pm. Then developed vague aching throughout lower back, shoulder, and hips. Progressed to shooting pains (mild) into both legs and down both arms into fingers and toes. muscle aches and pains persisted until 4pm on 1/7. Also developed inflamed lymph node under left arm pit.

Headache, significantly muscle/body aches, joint pain, significant fatigue. Continual, intermittent shooting abdominal pain.

Fever to 102.7F Rigors Nausea Myalgia All began morning after second vaccine and worsened throughout day

Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills Narrative

Muscle aches; joint pain; injection site pain; This is a spontaneous report from a non-contactable nurse reported for herself. A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date unknown), via an unspecified route of administration on left arm 05:30 PM on 04Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications include escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN). The patient previously took the first dose of bnt162b2 (lot number: EH9899) via an unspecified route of administration on arm left on 14Dec2020 at single dose for covid-19 immunisation. The patient experienced muscle aches, joint pain, injection site pain on 05Jan2021 04:00 AM after the second vaccine administrated, with outcome recovered. The patient received treatment for the events with Ibuprofen. No follow-up attempts are possible. No further information is expected.

R shoulder/upper arm pain that began suddenly, gradually worsened from 7/10 - 10/10. Pain radiated to middle upper back. Nausea. Anxiety.

Arm pain began on 1/2 at approximately 4 pm and gradually worsened. Was significantly improved by the next morning; however, lower back pain began around 4 pm on 1/3 and gradually worsened, peaking on 1/4 and 1/5. This is still slowly improving. Appears to be some sort of sacroiliac joint inflammation.

diarrhea; headache; lower back pain; Fatigue; arrhythmia; Tachycardia; High Blood pressure; Redness on chest; Chest tightness; Lightheaded; possible tongue swelling; possible tongue swelling (felt heavy after vaccine); dry mouth; sore throat; This is a spontaneous report from a contactable nurse (patient) who reported for herself that a 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration, on 20Dec2020 14:15 at left arm/arm right (pending clarification), single dose for COVID-19 immunization. Medical history included factor II, history of melanoma. She has no known allergies. She was not pregnant at the time of the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), ibuprofen (MOTRIN), multivitamin. Nurse reported administering COVID-19 vaccine at hospital, experiencing tachycardia, high blood pressure, redness on chest, chest tightness, lightheaded, possible tongue swelling (felt heavy after vaccine), arrhythmia, dry mouth, sore throat (after leaving emergency department) at 14:30 on 20Dec2020; After one day, she experienced diarrhea, headache, lower back pain and fatigue since 21Dec2020. Fatigue lasting for several days. Adverse events resulted in emergency room/department or urgent care (pending clarification). Nurse received intravenous diphenhydramine hydrochloride (BENADRYL) and fluids as treatments. Nurse assessed the events as non-serious. Nurse also reported that, prior to vaccination, she was not diagnosed with COVID-19; since the vaccination, she has not been tested for COVID-19. She did not receive other vaccine in four weeks. Outcome of fatigue was not recovered, outcome of the rest of the events was recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia, high blood pressure, arrhythmia and the other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Got the shot on 1/5/2021 around noon. In about 2 hours, started feeling soreness around the injection area. After 14 hours of the shot, started feeling chill, whole body joint and muscle pain, headache, fatigue, 99.5 fever. on 1/6, took Tylenol every 6 hours, three times in total, 1950 mg total dose. helped. felt a lot better on 1/7, the second day after the shot but still took 2 tablets of Tylenol before went to bed. on 1/8, felt totally fine.

hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/pains.

Flu-like symptoms including low-grade fever to 100.8, rigors, malaise, fatigue, myalgias (full body, not just right deltoid vaccination site). Also painful and tender right axillary lymphadenopathy. Symptoms began the morning following the second vaccination in the series and have so far lasted for the full day. (Note: I am reporting the symptoms on the day I am experiencing them; they are improved from this morning but not yet resolved.) Notably I had no symptoms after the first vaccination in the series except for very mild transient tenderness of the right deltoid at the vaccination site.

STARTED AT 1AM 1/8/2021 WITH CHILLS, STRONG HEADACHE, MODERATE GENERALIZED MUSCLE PAIN, PAIN LEFT ARM WITH ABDUCTION. LOWER BACK PAIN, MALAISE AND FATIGUE

Vax given 12/30/2020 at 2030. Sxs developed later with nausea, vomiting, dizzyness, myalgias, headache. Presented to ED. IVF, Zofran/diphenhydramine inj, tylenol. Neg COVID-19 test.

Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 02Jan2021 at 15:15 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. Concomitant medications were unknown. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Jan2021 at 19:00, the patient experienced tiredness, headache and muscle pain. No treatment was provided for the events tiredness, headache and muscle pain. The outcome of the events tiredness, headache and muscle pain was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Headache 24 hours after but nothing; uncontrollable/teeth chattering; chills; Fever; all over muscle aches; Injection site is sore and surrounding area is red; Injection site is sore and surrounding area is red; This is a spontaneous report from a contactable Other HCP. This 31-year-old female Other HCP (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on 30Dec2020 at 11:00 AM (at the age of 31-years) as single dose, Intramuscular into right arm for immunization. Medical history included COVID-19 virus test positive from 30Nov2020 to an unspecified date. Allergies were reported as none. Concomitant medications included magnesium citrate, magnesium oxide, riboflavin, tanacetum parthenium (MIGRELIEF) and curcuma longa rhizome, piper nigrum fruit (TURMERIC +). On 31Dec2020 (00:45), patient experienced headache 24 hours after vaccine but nothing to keep her from my normal activities. About 36-40 hours post vaccine on 01Jan2021 patient awoke with uncontrollable/teeth chattering chills with 101 Fahrenheit (F) fever and muscle aches. Fever broke after taking Tylenol severe. Temp at 5:30AM back down to 98.5F. Temp creeping up again to 99.5F at 11AM. Injection site is sore and surrounding area is red on 01Jan2021. The patient is experiencing all over muscle aches. The patient received treatment and controlled the fever with Tylenol. Lab data included body temperature 101, 98.5, 99.5 Fahrenheit all in Jan2021. Events 'Headache', 'teeth chattering', 'chills', 'fever', 'muscle pain', 'muscle pain' and 'Injection site is sore and surrounding area is red' were recovering.

raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination. Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.

Side effects started 12 hours after 2nd dose of vaccine (lot EL1284). I got chills, body aches, nausea, enlarged and swollen lymph node under left armpit that is warm to the touch and hurts.

First dose resulted in shoulder injury. Severe arm pain began evening after the first dose, followed by pain in the shoulder joint when raising arms above head which has persisted for 23 days. Second dose resulted in fever, chills, nausea, swelling of hands and flushing sensation in hands/feet, with maximum fever of 100.2 F documented 24 hours after the second dose. Fever and chills resolved about 36 hours after the injection.

- Sore shoulder for 2 days - overall body aches (comparable to the flu) for 2 days - malaise (Saturday I went to bed at 7pm and woke up at 6am Sunday morning still feeling tired - unusual for me) - light/swimmy headed for 2 days - decrease in appetite for 2 days Worst was on Saturday and Sunday was a little better. Asymptotic by Monday morning

Received second Pfizer covid vaccine. Felt extremely fatigue, joint pain, and pain in the injection site Friday night at work. Saturday night felt extremely fatigue.

Increased swelling and pain in underarm on side of injection. Injection was about at 0800 on 1/9, pain began around 1900 1/9 and woke up with swelling and worsening tenderness on 1/10 at 0800. Swelling and pain continued into 1/11 and has not improved. No palpable lymph nodes

I got fatigue a few hours after vaccine and resolved after a nap of 3 hours. My arm also still has soreness at the injection sight when touch and area around my underarm hurts with movement.

After 24 hours of receiving vaccine my lower back started to ache, I experienced body chills and my skin was sensitive to touch. This lasted for about 6 hours. I was also light headed and woozy for about 3 hours. The next morning all of these symptoms were gone.

it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad.; pain in right leg and bottom sole of right foot; hurts to speak; numbness right upper side of lip; pins and needle feeling right upper quadrant of face; pain and dull aching right upper side of face; right hand numbness, wasn't able to feel anything; generalized headache; generalized muscle weakness and pain; generalized muscle weakness and pain; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose in deltoid right for covid-19 immunization. There were no medical history or concomitant medications. The patient received the vaccine on 03Jan2021 and within 15 minutes had a generalized headache. Later that night she had generalized muscle weakness and pain, but really didn't think too much about it. The next day at work (04Jan2021), she had numbness on the right upper side of her lip and a pins and needle feeling in the right upper quadrant of the face. Had a lot of pain in the area as well on the right upper side of the face as well as a dull aching pain that lasted for hours. Later that day when using the computer and she was trying to reach for her mouse she noticed her right hand wasn't able to feel anything and that lasted about 20-25 minutes. Kept slapping the mouse with her hand, but could not feel anything, her hand went numb. Yesterday (05Jan2021), she had the same pins and needle feeling in the same area of the face and that dull achy feeling and it occurred for hours and it was very kind of debilitating for her at work. Later that night she had pain in her right leg and felt the same way, that very severe achiness, which was the pins and needles feeling up and down the leg and underneath the right foot. All these symptoms tend to be on her right side and it definitely lasted for hours. It started about 1 and didn't end until 6-7pm. It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad. This morning (06Jan2021) she had to call out of work because at 3am the generalized headache, pain was unbearable. She was still experiencing the pain in right leg and bottom sole of right foot. She did not receive any vaccines the same day or 4 weeks prior. No problems with vaccines in past. She had made an appointment with a neurologist and will have a MRI done on Friday, 08Jan2021. No further details provided. All events required a visit to physician office. All events were reported as serious per medically significant. The outcome of all events was not resolved. The reporter considered all events were related to the vaccine. Information about Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

2nd dose I began having muscle aches around 10pm (about 10 hours post 2nd dose) then I woke up in the night at 1am ( about 13 hours post injection) with a fever of 101.4, muscle aches (my legs, arms, neck, and back), chills, and sinus dryness. This was controlled 3 hours later by tylenol. For the next 36 hours post symptom onset my sinuses were still affected, my muscles felt very weak and the glands in my neck felt swollen. Everything has resolved except the swollen glands in my neck and my sinsuses being dry and painful.

I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By 2030 I had severe full body chills and could not stop shaking. I had a severe headache/migraine. Every muscle in my body hurt. This continued on for the entire night. Got tested for COVID the next morning with the rapid results and the symptoms continued with the muscle aches and severe headache. Vision became blurry and I became very dizzy. Slept for 8 hours during the day on 1/7/2021 and then slept another 12 hours that night. The body aches and headaches continued until 1/8/2021 at which the symptoms finally subsided

Shortly after receiving 2nd dose she reported feeling strange sensation in her right arm. States her arm felt heavy and experienced some numbness and tingling up the right side of her face. On 1/12/21 she woke up and felt tingling on the right side of her face and swelling. She was evaluated in the Emergency Department and treated with Dexamethasone 10mg IM x1 dose and prescribed Prednisone 20mg daily x 5 days.

She received the second dose of the COVID-19 vaccine yesterday. Shortly after that she started to feel some strange sensation in her arm. States her arm felt "heavy". She went home and then felt like she had potentially some numbness and tingling up the right side of her face. She did receive the shot in the right deltoid. Patient states she has no weakness in her arms or legs. But they do feel "heavy". Patient states this morning she felt like the tingling sensation on the right side of her face had improved but it felt more swollen than it did yesterday. She states her family members came over this morning and they also felt that she had some swelling to the right side of her face. Patient was administered Dexamethasone 10mg IM x1 dose and prescribed Prednisone 20mg daily x 5 days then follow-up with PCP

On 12/25 I was driving home and my left arm got numb, tingly and weak to the the point where I thought I was suffering from a stroke. I rushed to my moms and had her to drive me to the hospital where they did a neuro check to include a CT scan which ruled out the stroke but the symptoms lasted about 4 days which came and went with the pain and intensity varying each time which ended around 12/29. I suffered from body aches and night chills one night. Around the 12/29 I began to have pressure around the back of my head which felt as if I was laying on bricks when I laid down. It got to the point to where I couldnt sleep which caused me to go back to the ER on 1/1 where I was given toradol, decadron and sudafed which allowed me to sleep. I was released from the ER with Motrin 800 and contined to take that and Tylenol until the headaches ceased which was about 3 or 4 days later. The headache went away but the pressure still remained. My lymph glands were swollen so I was also given a prescription for amoloxicillin.